Closure Mechanisms and Seal Integrity Indicators for Sterilization Containers

ABSTRACT

Closure mechanisms for closing and sealing sterilization containers and indicators for indicating the seal integrity sterilization containers are provided. For example, a container closure mechanism may be configured to distribute a closure force along a gasket to seal a container lid to a container body. Further, a seal indicator may visibly indicate at the container exterior whether the container is sufficiently sealed to prevent an ingress of contaminants into the container. If the container is sufficiently sealed, the seal indicator is a first state, and if the sterilization container is not sufficiently sealed, the seal indicator is in a second state. Thus, the seal indicator undergoes a state change when the sterilization container transitions from unsealed to sealed or from sealed to unsealed, such that a user can ascertain whether the container is properly sealed to maintain sterility or whether the seal and sterility of the container have been compromised.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 62/757,852, filed Nov. 9, 2018, the contents of which areincorporated herein by reference.

FIELD

The subject matter of the present disclosure relates generally tosterilization containers and, more particularly, to rigid sterilizationcontainers with features for closing and sealing the sterilizationcontainer and for indicating that the sterilization container isproperly sealed.

BACKGROUND

Personnel in a sterilization station, such as the Central Service Room(CSR) or the Sterile Processing Department (SPD) of hospitals, arecommonly charged with the responsibility of packaging surgical suppliesto ensure that the sterility of the packaged contents is maintained fromsterilization to the point of reuse. Several activities are involved inthe task of sterile supply delivery to the operating room and otherunits, such as a cardiac catheterization lab, emergency room, labor anddelivery room, intensive care unit, pediatric care unit, specializedburn care units, and other surgical or medical units.

Many of the surgical instruments and supplies used in an operating room(OR), or other surgical or medical unit, are reusable. These suppliestypically include such things as clamps, scalpel blade handles,retractors, forceps, scissors, surgeon's towels, basins, and the like.All of these supplies must be collected after each procedure,decontaminated, washed and dried before placing into a sterilizationpackaging system, and sterilized before they can be used again inanother procedure. The sterilization packaging systems used must be ofthe size and shape to accommodate the items to be sterilized, must becompatible with and withstand the physical conditions of the cleaning,disinfection, and sterilization modality processes, and must be capableof maintaining the sterility of their contents post-sterilization.

Typical means of sterilizing surgical instruments, medical devices oraccessories include, among others, steam sterilization (e.g., adynamic-air-removal type such as a prevaccum cycle or steam-flushpressure-pulse (SFPP) cycle), exposure to ethylene oxide gas, andexposure to hydrogen peroxide plasma, as is done with the STERRAD®Sterilization System from Advanced Sterilization Products, Irvine,Calif. or as done with AMSCO V-PRO® Low Temperature SterilizationSystems using Vaporized Hydrogen Peroxide (VHP®) from STERIS. After thesterile barrier system and its contents have been sterilized, thesterilization sterile barrier system typically is stored until it isneeded for a surgical or other medical procedure, or in some cases maybe use immediately.

Common sterile barrier systems, also known as sterilization packagingsystems, include sealable pouches, sterilization wraps, and rigidcontainers. Although each of these systems has some advantage comparedto other systems, each of these typical packaging systems also hasdrawbacks. As an example, a rigid sterilization container will permitthe entry of sterilizing vapor/gas or other medium to sterilize thecontents of the container while denying the ingress of contaminants suchas bacteria and other infection causing materials or their vehiclesafter sterilization. As such, rigid sterilization containers generallyprovide a consistent barrier against the ingress of contaminants.However, it is difficult to detect if the main seal of typical rigidsterilization containers is properly formed. That is, with the sealgasket integrated within the rigid sterilization container's lid, it isdifficult to ascertain that the main seal has properly formed formaintaining the sterility of the container contents post sterilization.Further, it is difficult to detect if the seal gasket is damaged, whichcould hinder the gasket in the rigid sterilization container fromcreating an adequate seal against contamination reaching of thecontents. Therefore, without opening the rigid sterilization container,one typically does not know if the main seal has maintained its closureor sterility has been maintained from when the rigid sterilizationcontainer left the sterilization station to when the contents of therigid sterilization container are presented for use, e.g., in the OR,where aseptic presentation of the contents is desired. Moreover, mostcurrent rigid containers utilize a dual latching mechanism, i.e., alatch or lock on each end of the container, which does not adequatelydistribute the closure force along the four sides of the container.

Consequently, there is a need for a sterilization container thatovercomes the shortcomings of known containers. In particular, anindicator for relatively quickly indicating to a user whether asterilization container is or is not properly sealed, without requiringthe user to open the container, would be advantageous. A sterilizationcontainer incorporating a visual seal indicator would be desirable. Asterilization container having improved means for closing the container,e.g., to ensure the container is properly sealed, also would bebeneficial. For example, a closure mechanism that adequately anduniformly distributes a closing force along the gasket would be useful.

SUMMARY

The present invention provides sterilization containers with featuresfor attaching a lid to a body of the container to seal an interiorvolume against an ingress of contaminants. The present disclosurefurther provides features for closing and sealing a sterilizationcontainer such that the closure force is distributed more uniformlyalong a sealing gasket of the container. The present disclosure alsoprovides visual seal indicators for indicating whether a sterilizationcontainer is sealed against an ingress of contaminants. Additionalaspects and advantages of the invention will be set forth in part in thefollowing description, may be apparent from the description, or may belearned through practice of the invention.

In one aspect, the present subject matter is directed to a sterilizationcontainer that comprises a body and a lid that together define aninterior, a closure mechanism for securing the lid to the body, and agasket for sealing the interior against an ingress of contaminants. Thebody includes a first end, a second end opposite the first end, a firstside extending between the first and second ends, and a second sideopposite the first side and extending between the first and second ends.The body further includes an open top portion. The closure mechanismcompresses the gasket between the lid and the body to seal the interioragainst the ingress of contaminants.

In another aspect, the present subject matter is directed to asterilization container that comprises a body and a lid that togetherdefine an interior, a gasket for sealing the interior against an ingressof contaminants, and a seal indicator for indicating a seal state of thesterilization container. The seal indicator has a first indicator statethat indicates an unsealed container state and a second indicator statethat indicates a sealed container state. The seal indicator is in thefirst indicator state when the gasket is not compressed to seal thesterilization container against the ingress of contaminants, and theseal indicator is in the second indicator state when the gasket iscompressed to seal the sterilization container against the ingress ofcontaminants.

In still another aspect, the present subject matter is directed to asterilization container that comprises a body and a lid that togetherdefine an interior, a closure mechanism for securing the lid to thebody, a combination gasket/filter, and a seal indicator for indicating aseal state of the sterilization container. The combination gasket/filterhas a gasket for sealing the interior against an ingress of contaminantsintegrally formed with filter media for forming a barrier between anexternal environment and the interior. The seal indicator has a firstindicator state that indicates an unsealed container state and a secondindicator state that indicates a sealed container state. The closuremechanism compresses the combination gasket/filter between the lid andthe body to seal the interior against the ingress of contaminants. Theseal indicator is configured to display a first indicium in the firstindicator state and is configured to display a second indicium in thesecond indicator state.

These and other features, aspects, and advantages of the presentinvention will become better understood with reference to the followingdescription and appended claims. The accompanying drawings, which areincorporated in and constitute a part of this specification, illustrateembodiments of the invention and, together with the description, serveto explain the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A full and enabling disclosure of the present invention, including thebest mode thereof, directed to one of ordinary skill in the art, is setforth in the specification, which makes reference to the appendedfigures, in which:

FIG. 1 provides a perspective view of a sterilization container in aclosed state, where the sterilization container is sealed against aningress of contaminants, according to an exemplary embodiment of thepresent subject matter.

FIG. 2 provides a perspective view of the sterilization container ofFIG. 1 in an open state, where the sterilization container is not sealedagainst the ingress of contaminants.

FIG. 3 provides a perspective view of a sterilization container in aclosed state, where the sterilization container is sealed against aningress of contaminants, according to another exemplary embodiment ofthe present subject matter.

FIG. 4 provides a schematic cross-section view of a sterilizationcontainer in an open state, with a visual seal indicator indicating acorresponding first seal state of the sterilization container.

FIG. 5 provides the schematic cross-section view of FIG. 4, with thesterilization container in a closed state and the visual seal indicatorindicating a corresponding second seal state of the sterilizationcontainer.

FIG. 6 provides a perspective view of a sterilization container in aclosed state, where the sterilization container is sealed against aningress of contaminants, according to another exemplary embodiment ofthe present subject matter.

FIG. 7 provides an exploded view of the sterilization container of FIG.6.

FIG. 8 provides a cross-section view of a sealing assembly and a portionof a latch assembly of a sterilization container, according to anexemplary embodiment of the present subject matter.

FIG. 9 provides a perspective view of a sterilization container in aclosed state, where the sterilization container is sealed against aningress of contaminants, according to yet another exemplary embodimentof the present subject matter.

FIG. 10 provides an exploded view of the sterilization container of FIG.9, as well as a perspective view of additional lid and combinationgasket/filter assemblies that may be used with the sterilizationcontainer.

FIG. 11 provides a perspective view of a portion of the sterilizationcontainer of FIG. 9, illustrating a lid of the sterilization containerin an unsecured state, in which the sterilization container is unsealed,and a secured state, in which the sterilization container is sealed.

FIG. 12 provides a perspective view of the sterilization container ofFIG. 9 with the lid of the sterilization container being manipulated bya user.

FIG. 13 provides a perspective view of a sterilization container in aclosed state, where the sterilization container is sealed against aningress of contaminants, according to still another exemplary embodimentof the present subject matter.

FIG. 14 provides an exploded view of the sterilization container of FIG.13, as well as a perspective view of additional combinationgasket/filter assemblies that may be used with the sterilizationcontainer.

FIG. 15 provides a perspective side view of a portion of thesterilization container of FIG. 13, with a first end member of a gasketof the combination gasket/filter unsecured from a second end member ofthe gasket such that the gasket is in an untightened or non-stretchedconfiguration.

FIG. 16 provides the perspective side view of FIG. 15, with the firstend member secured with the second end member such that the gasket is ina tightened or stretched configuration to seal the sterilizationcontainer and with a tag, such as a tamper evidence tag, secured at thefirst and second end members.

DETAILED DESCRIPTION

Reference now will be made in detail to embodiments of the invention,one or more examples of which are illustrated in the drawings. Eachexample is provided by way of explanation of the invention, notlimitation of the invention. In fact, it will be apparent to thoseskilled in the art that various modifications and variations can be madein the present invention without departing from the scope or spirit ofthe invention. For instance, features illustrated or described as partof one embodiment can be used with another embodiment to yield a stillfurther embodiment. Thus, it is intended that the present inventioncovers such modifications and variations as come within the scope of theappended claims and their equivalents.

Described herein are a sterilization packaging system or container andcomponents thereof suitable for use in a variety of procedures forcontaining, sterilizing, storing, and using sterilized items such assurgical devices, instruments, or supplies. While described inconjunction with its use in surgical room procedures located inhospitals or ambulatory surgical facilities, the present subject matteris intended for use wherever there is a need for containerizedsterilized devices, instruments, or materials. Consequently, thefollowing description should not be considered a limitation as to thescope of use of the present subject matter.

Generally, the present subject matter provides closure mechanisms forclosing and/or sealing a container against an ingress of contaminants,as well as indicators for indicating the integrity of a seal. Forexample, described herein are various closure mechanisms forsterilization containers that apply a more uniform force to a sealinggasket of the container. A more uniform force along the gasket can helpensure the gasket establishes a proper seal between a lid and a base orbody of the container, as well as retains the seal between the lid andbody over time, e.g., before, during, and after a sterilization process,which includes delivery of a sterilization agent such as steam, ethyleneoxide, hydrogen peroxide plasma, etc. to an interior of the container tosterilization the container's contents.

Further, described herein are seal indicators of sterilizationcontainers that indicate whether the sterilization container issufficiently sealed to prevent an ingress of contaminants into thesterilization container. If the sterilization container is sufficientlysealed, the seal indicator is in one state, and if the sterilizationcontainer is not sufficiently sealed, the seal indicator is in anotherstate. Thus, the state of the sterilization container is communicated toa user through visible indicia of the seal indicator. That is, the sealindicator undergoes a visible change in state when the sterilizationcontainer transitions from not being sealed, e.g., when articles arebeing placed in the container for sterilization, to being sealed, e.g.,when a lid of the container is properly secured to a body of thecontainer, such that the user may be assured that the container isproperly sealed to maintain sterility of the articles thereinpost-sterilization. Moreover, the seal indicator undergoes a visiblechange in state if the seal is broken after the lid is secured to thecontainer, to signal to the user that the seal has been breached suchthat the articles in the container may no longer be sterile. However,the seal indicator does not undergo a state change when the container issubjected to a sterilization process or protocol, i.e., the state changeassociated with the closure or sealing of sealing of the container isunaffected by the sterilization modality. The present subject matteralso provides methods for indicating a seal state of a sterilizationcontainer.

Turning now to FIGS. 1 through 3, additional embodiments of the presentsubject matter will be described. FIGS. 1 and 2 each provide aperspective view of a sterilization container 300 comprising a body 302and a cover or lid 304, according to an exemplary embodiment of thepresent subject matter. FIG. 3 provides a perspective view of thecontainer 300, having the body 302 and lid 304, according to anotherexemplary embodiment of the present subject matter. The body 302 and lid304 together define an interior 306 of the sterilization container 300.One or more articles, e.g., clamps, scalpel blade handles, retractors,forceps, scissors, surgeon's towels, basins, and like surgical devices,instruments, or supplies, may be placed in the interior 306 of thecontainer 300 for sterilization such that the article(s) may be reusedin another procedure. It will be appreciated that the sterilizationcontainer 300 may generally have the form of a parallelepipedal boxshape as shown in FIGS. 1-3, and the container 300 may have anyappropriate size for containing the article(s) to be sterilized.

In FIGS. 1 and 3, the sterilization container 300 is closed and sealedagainst an ingress of contaminants. That is, the body 302 includes anopen top portion 308, but when the lid 304 is secured to the body 302 asshown in FIGS. 1 and 3, the lid 304 covers the open top portion 308 ofthe body 302 and a gasket 310 (FIGS. 4, 5) is compressed between the lid304 and body 302 to seal the container 300 against an ingress ofcontaminants, as described in greater detail herein. In FIG. 2, thesterilization container 300 is open and, thus, is unsealed or not sealedagainst the ingress of contaminants. More specifically, the lid 304 isseparated from the body 302 to expose the interior 306 of the container300.

As shown in FIGS. 1 and 2, the lid 304 is retained on the body 302 byone or more latch assemblies 312, and in FIG. 3, the lid 304 is retainedon the body 302 by one or more latch assemblies 350. The latchassemblies 312, 350 form a closure mechanism for securing the lid 304 tothe body 302 and sealing the container interior 306 and are described ingreater detail herein. Further, the container 300 includes one or morehandles 314 for lifting, carrying, or otherwise handling the container300. For example, a first handle 314 may be attached to a first end 302a of the body 302, and a second handle 314 may be attached to a secondend 302 b of the body 302, where the second end 302 b is opposite thefirst end 302 a. In other embodiments, a first handle 314 may beattached to a first side 302 c of the body 302, and a second handle 314may be attached to a second side 302 d of the body 302, where the secondside 302 d is opposite the first side 302 c and the first and secondsides 302 c, 302 d extend between the first and second ends 302 a, 302b. Other configurations and/or placements of one or more handles 314 maybe used as well.

As further depicted in FIGS. 1-3, a visual indicator 316 provides avisual indication of a seal state of the sterilization container 300.For instance, the visual indicator 316 indicates to a user of thecontainer 300 whether the container 300 is in a first, unsealed state,where the container 300 is not sealed against an ingress of contaminants(i.e., contaminants could enter the container 300), or a second, sealedstate, where the container 300 is sealed against the ingress ofcontaminants (i.e., contaminants cannot enter the container 300). Thatis, the visual indicator 316 is a binary indicator of the integrity ofthe seal between the body 302 and lid 304 of the container 300, e.g.,the indicator 316 indicates when the seal is established and when theseal is broken or otherwise comprised. More particularly, the sealindicator 316 has a first indicator state that indicates the unsealedcontainer state and a second indicator state that indicates the sealedcontainer state. The seal indicator 316 is visible to a user of thecontainer 300 from the container exterior to signal to the user whetherthe container 300 is sealed or unsealed. A change in state, i.e., fromthe first indicator state to the second indicator state or from thesecond indicator state to the first indicator state, may be achieved bya change in color, shape, size, position, etc. of the seal indicator 316to signal the container 300 has transitioned from its unsealed state toits sealed state or from its sealed state to its unsealed state. Thechange in state by the visible seal indicator 316 relatively quicklycommunicates to the user the seal state of the container 300, withoutrequiring the user to open the container 300. Further, the sealindicator 316 is unaffected by the sterilization modality to which thecontainer 300 is subjected to sterilize the articles within thecontainer 300. The visual indicator 316 is described in greater detailherein.

As previously described, the seal between the container body 302 and lid304 is established by the gasket 310. The gasket 310 extends between thebody 302 and lid 304; for example, the gasket 310 extends about aperimeter of the open top portion 308 of the body 302 and an interfaceportion of the lid 304. Securing the lid 304 to the body 302 compressesthe gasket 310 between the body 302 and lid 304 to seal the interior306. When the gasket 310 is not compressed, or not fully compressed,such that the interior 306 is not sealed against the ingress ofcontaminants, the container 300 is in its first, unsealed state and theseal indicator 316 is in its first indicator state. Similarly, when thegasket 310 is fully compressed, such that the interior 306 is sealedagainst the ingress of contaminants, the container 300 is in its second,sealed state and the seal indicator 316 is in its second indicatorstate.

As described in greater detail herein, in some embodiments of sealindicators, such as seal indicator 316, the seal indicator is configuredto display a first indicium in the first indicator state and isconfigured to display a second indicium in the second indicator state.The first indicium may be a first color or hue and the second indiciummay be a second color or hue, and the first and second colors or huesmay be selected such that there is a high contrast between thecolors/hues and/or between the colors/hues and the sterilizationcontainer, and/or the colors/hues may be selected to reinforce thesignal communicated by the color or hue. For example, in an exemplaryembodiment, the first color is red to indicate the container 300 isunsealed (i.e., contaminants could enter the container 300 and reach anyarticles in the interior 306), and the second color is green to indicatethe container 300 is sealed (i.e., contaminants cannot enter thecontainer 300 and any articles in the container 300 would remain sterileafter sterilization). Thus, the seal indicator 316 is configured todisplay the first color when the container 300 is unsealed and thesecond color when the container 300 is sealed, such that the sealindicator 316 indicates a change in the seal state of the container 300through a change in color.

Further, as previously stated, rather than a dual colored indicator, theseal indicator 316 may comprise other features for indicating the sealstate of the container 300. As an example, the first indicium may be afirst visual pattern and the second indicium may be a second visualpattern, such that the seal indicator 316 displays the first patternwhen the container 300 is in the first, unsealed state and displays thesecond pattern when the container 300 is in the second, sealed state.Other visual indicia, e.g., images, color differences, words, etc., andother types of indicators, such as auditory or other non-visualindicators, may be used as well.

Keeping with FIGS. 1 and 2, different configurations of the lid 304 areillustrated that may be used in the exemplary embodiment of container300. As shown in FIG. 1, in some embodiments the lid 304 defines one ormore vents 318 in a top surface 305 of the lid 304. In other embodimentsof the lid 304, the lid 304 does not define vents 318 in the top surface305, as shown in FIG. 2, but the vent(s) 318 are defined elsewhere inthe container 300, e.g., in one or more side surfaces 307 of the lid 304that are generally orthogonal to the top surface 305, in the body 302,or in both the lid 304 and the body 302. The vent(s) 318 permit fluids,such as air, steam, and chemical sterilization agents and/or othersterilants, to pass through the lid 304 and into the interior 306 of thesterilization container 300, e.g., to sterilize the contents of thecontainer 300, as well as to pass from the interior 306 to an exteriorenvironment, e.g., to help the contents of the container 300 dry after asterilization process.

A filter (not shown) is positioned within the sterilization container300 adjacent the vent(s) 318 to prevent contaminants from entering theinterior 306. For example, the filter may be a sheet of material thatextends over the open top portion 308 of the body 302 such that thefilter is positioned between the lid 304 and the container interior 306.However, the filter need not be configured as a sheet but may have anysuitable configuration or construction. Further, the filter can be madefrom a number of materials and, generally, may be made of a materialfrom one of two main classes, reusables and disposables. Reusables arematerials that, as the name suggests, can be reused, typically bywashing or some other form of cleaning. Disposables, on the other hand,usually are one-use items that are discarded or recycled after theirinitial use. Generally, cloth, linen, or other woven materials fall intothe reusable category while disposables normally include nonwovenmaterials made from either or both natural and synthetic fibers such aspaper, fibrous polymeric nonwovens, and films, which are capable ofpassing sterilants and retarding transmission of bacteria and othercontaminants.

Nonwoven sterilization materials present several advantages due to theirbarrier properties, economics, and consistent quality. The nonwovenmaterials can be made from a variety of processes including, but notlimited to, air laying processes, wet laid processes, hydroentanglingprocesses, spunbonding, meltblowing, staple fiber carding and bonding,and solution spinning. The fibers themselves can be made from a varietyof both natural and synthetic materials including, but not limited to,cellulose, rayon, nylon, polyesters, polyolefins, and many othermaterials. The fibers may be relatively short, staple length fibers,typically less than three inches, or longer and substantially morecontinuous fibers such as are produced by spunbonding and meltblowingprocesses. Whatever materials are chosen, the resultant filter materialmust be compatible with the particular sterilization technique beingused and must also provide both strength and barrier properties tomaintain the sterile nature of the contents of the sterilizationcontainer 300 until use.

In some embodiments, the lid 304 may define a window through which thefilter is visible to a user of the container 300, and the filter mayalso define a window, formed from a transparent breathable film or thelike that still provides a barrier against contaminants, such that theuser can see through the filter and into the interior 306 of thecontainer 300. Such windows through the lid and filter allow the userto, e.g., verify contents of the container 300, reducing the need toopen containers to find specific instrument sets, as well as view anyinternal indicators, if provided, which may be indicators of sealintegrity or whether the container 300 has undergone a sterilizationprocess. However, in other embodiments, the filter may be made from atranslucent or opaque material, such as, e.g., an SMS material,polytetrafluoroethylene (PTFE), paper, or the like. For example,polyolefin-based fibers and their resultant nonwovens are particularlywell-suited for the production of a flexible filter, and a polypropylenespunbonded nonwoven can be used to impart strength characteristics tothe filter. In some embodiments, the filter may be made from laminatessuch as a laminate of spunbonded and meltblown or spunbonded, meltblown,spunbonded to impart both strength and barrier properties to the filter.A spunbonded-meltblown-spunbonded (SMS) material is made from threeseparate layers that are laminated to one another. The method of makingthese layers is known and described in U.S. Pat. No. 4,041,203 to Brock,et al., which is incorporated herein in its entirety by reference. Thematerial of Brock, et al. is a three layer laminate ofspunbonded-meltblown-spunbonded layers. The two outer layers of SMS area spunbonded material made from extruded polyolefin fibers, orfilaments, laid down in a random pattern and then bonded to one another.The inner layer is a meltblown layer also made from extruded polyolefinfibers generally of a smaller diameter than the fibers in the spunbondedlayers. As a result, the meltblown layer provides increased barrierproperties due to its fine fiber structure, which permits thesterilizing agent to pass through the fabric while preventing passage ofbacteria and other contaminants. Conversely, the two outer spunbondedlayers provide a greater portion of the strength factor in the overalllaminate. The laminate may be prepared using an intermittent bondpattern that is preferably employed with the pattern being substantiallyregularly repeating over the surface of the laminate. The pattern isselected such that the bonds may occupy about 5% to about 50% of thesurface area of the laminate. Desirably, the bonds may occupy about 10%to about 30% of the surface area of the laminate. In an exemplaryembodiment, the filter is made from an SMS material, but the filter alsomay be made from other suitable materials.

With respect to FIG. 3, although shown without vents 318 in the lid 304,it will be appreciated that the sterilization container 300 is vented insome fashion to allow fluids, such as air and sterilants, to enter andexit the container 300. As described with respect to FIGS. 1 and 2, insome embodiments, the vents 318 are defined in the top surface 305 ofthe lid 304, but in other embodiments, the vents 318 are defined in oneor more side surfaces 307 of the lid 304 that are generally orthogonalto the top surface 305. In other embodiments, the vents 318 may bedefined in the body 302, or in both the lid 304 and the body 302. Aspreviously described, a filter is disposed between the vent openings 318and the container interior 306 to prevent contaminants from entering theinterior 306.

Referring still to FIGS. 1-3, the lid 304 has top surface 305 that facesaway from the body 302. Further, the lid 304 includes a first end 304 aopposite a second end 304 b and a first side 304 c opposite a secondside 304 d. The first and second sides 304 c, 304 d extend between thefirst and second ends 304 a, 304 b. Once the lid 304 is secured to thebody 302 as described in greater detail below, the gasket 310 iscompressed between the body 302 and lid 304, preventing contaminantsfrom entering the container interior 306 defined by the body 302 and lid304.

Referring particularly to FIGS. 1 and 2, the container 300 includes alatch assembly 312 for securing the lid 304 to the body 302 and forcompressing the gasket 310 between the lid 304 and body 302 to seal theinterior 320. The latch assembly 312 is symmetrical about a longitudinalmidline L_(M) of the lid 304 such that the latch assembly 312, as wellas the remainder of the container 300, is the same on a first half thatincludes the lid first end 304 a and body first end 302 a as on a secondhalf that includes the lid second end 304 b and body second end 302 b.Thus, it will be understood that, although not shown completely in thefigures, the lid second end 304 b and body second end 302 b include thesame or identical features as shown on the lid first end 304 a and bodyfirst end 302 a, and the lid second side 304 d and body second side 302d include the same or identical features as shown on the lid first side304 c and body first side 302 c.

In the exemplary embodiment shown in FIGS. 1 and 2, the latch assembly312 includes a first arm 322 attached to the lid 304 and pivotable withrespect to the lid 304, a second arm 324 attached to the lid 304 andpivotable with respect to the lid 304, a pair of first hooks 326extending from the first arm 322 to the body 302, and a pair of secondhooks 328 extending from the second arm 324 to the body 302.Additionally, the latch assembly 312 includes a pair of end latches 330;a first end latch 330 is attached to the first arm 322 and a second endlatch 330 is attached to the second arm 324. The first arm 322 extendsabout a first portion 305 a of the top surface 305 of the lid 304, andthe second arm 324 extends about a second portion 305 b of the topsurface 305 of the lid 304.

To secure the lid 304 with respect to the body 302, the hooks 326, 328engage the sides 302 c, 302 d of the body 302 and the end latches 330engage the ends 302 a, 302 b of the body 302. More particularly, onefirst hook 326 releasably attaches to a side catch 334 on the first side302 c of the body 302 and the other first hook 326 releasably attachesto a side catch 334 on the second side 302 d of the body 302 to compressthe first arm 322 against the lid 304. To compress the second arm 324against the lid 304, one second hook 328 releasably attaches to a firstside catch 336 on the first side 302 c of the body 302 and the othersecond hook 328 releasably attaches to a second side catch 336 on thesecond side 302 d of the body 302. Further, the first arm end latch 330extends from the first arm 322 to the body 302 and engages an end catch338 on the first end 302 a of the body 302. Similarly, the second armend latch 330 extends from the second arm 324 to the body 302 andengages a second end catch 338 on the second end 302 b of the body 302.As best illustrated in FIG. 2, each end catch 338 may be disposed on aportion of the respective body end 302 a, 302 b that is recessed withrespect to the remainder of the end 302 a, 302 b.

It will be appreciated from FIGS. 1 and 2 that each of the end latches330 includes at least one element that is pivotable or rotatable withrespect to the respective first arm 322 or second arm 324 to engage andto disengage from the body 302. For example, a support 340 may beattached to each arm 322, 324, and a pin 342 may extend through each endlatch 330 to pin the latch to its respective support 340. As such, therespective end latch 330 is secured to its support 340 but can pivot orrotate about its pin 342. By grasping the end latch 330 and pivoting orrotating the end latch 330 with respect to its arm 322, 324, a user candisengage the end latch 330 from its respective end catch 338 or engagethe end latch 330 with its respective end catch 338.

Additionally, in the depicted exemplary embodiment, each of the firstarm 322 and the second arm 324 are formed from a generally cylindricalmaterial such that each arm 322, 324 has a generally circular or roundcross-section. For example, each arm 322, 324 may be formed from arelatively thick metallic wire that is manipulated into the desiredoutline for each arm 322, 324, e.g., by bending. More particularly, thefirst arm 322 comprises a first segment 322 a, a second segment 322 b,and a third segment 322 c. The first, second, and third segments 322 a,322 b, 322 c of the first arm 322 are arranged such that the firstportion 305 a of the lid top surface 305 includes the lid first end 304a, a portion of the lid first side 304 c, and a portion of the lidsecond side 304 d. An end 344 of each of the first and third segments322 a, 322 c of the first arm 322 is secured to the lid 304 near thelongitudinal midline L_(M) of the lid 304. The first arm 322 pivotsabout the ends 344. Similarly, the second arm 324 comprises a firstsegment 324 a, a second segment 324 b, and a third segment 324 c suchthat the second arm 324 is a mirror image of the first arm 322. Thefirst, second, and third segments 324 a, 324 b, 324 c of the second arm324 are arranged such that the second portion 305 b of the lid topsurface 305 includes the lid second end 304 b, a portion of the lidfirst side 304 c, and a portion of the lid second side 304 d. An end 346of each of the first and third segments 324 a, 324 c of the second arm324 is secured to the lid 304 near the longitudinal midline L_(M) of thelid 304. The second arm 324 pivots about the ends 346.

Moreover, the lid 304 defines a groove 348 in its top surface 305 forreceipt of each of the first arm 322 and the second arm 324. The groove348 is defined inward of each of the first and second ends 304 a, 304 band first and second sides 304 c, 304 d of the lid 304 such that thegroove 348 is offset from each of the first and second ends 304 a, 304 band first and second sides 304 c, 304 d of the lid 304. Further, thegroove 348 has a shape complementary to the shape of the first arm 322and the second arm 324 such that both the first arm 322 and second arm324 are recessed within the groove 348 when the first and second arms322, 324 are received in the groove 348.

Accordingly, the exemplary embodiment of the sterilization container 300shown in FIGS. 1 and 2 features a closure mechanism that may be referredto as a picnic basket-style closure mechanism. To open the container300, each arm 322, 324 on top of the lid 304 pivots upward toward aplane extending through the longitudinal midline L_(M) of the lid 304,which is the longitudinal center of the container 300. To close thecontainer 300, the arms 322, 324 pivot downward until they are receivedin the groove 348 defined in the lid 304. End latches 330 and side hooks326, 328 extend from the arms 322, 324 and attach to the container body302 to secure the lid 304 to the body 302 and to compress the gasket 310to seal the interface between the lid 304 and body 302 such thatcontaminants cannot interior the container interior 320.

Turning now to FIG. 3, an alternative exemplary embodiment of the picnicbasket-style closure mechanism for exemplary sterilization container 300will be described. Similar to the embodiment shown in FIGS. 1 and 2, theembodiment shown in FIG. 3 has a latch assembly 350 for securing the lid304 to the body 302 and compressing the gasket 310 between the lid 304and body 302. The latch assembly 350 includes a pair of arms 352, 354that each extend around a portion of the top surface 305 of the lid 304to secure the lid 304 to the body 302. However, unlike the embodiment ofFIGS. 1 and 2, in which the arms 322, 324 are offset from an outer edge303 of the lid 304, the arms 352, 354 of the embodiment of FIG. 3 extendaround the edge 303 of the lid 304. The first arm 352 extends around thefirst end 304 a and a portion of each of the first and second sides 304c, 304 d of the lid 304, and the second arm 354 extends around thesecond end 304 b and a portion of each of the first and second sides 304c, 304 d of the lid 304. Each of the first arm 352 and second arm 354 ishinged near the lid longitudinal midline L_(M); that is, each arm 352,354 is pivotably attached to the lid 304 near the longitudinal midlineL_(M) such that the arms 352, 354 can pivot toward and away from the lid304. The arms 352, 354 pivot upward or away from the lid 304 to unsecurethe lid 304 from the body 302 the sterilization container 300, and thearms 352, 354 pivot downward or toward the lid 304 to secure the lid 304with respect to the body 302 and to seal the container interior 306against the ingress of contaminants.

Similar to the embodiment illustrated in FIGS. 1 and 2, the latchassembly 350 of the embodiment illustrated in FIG. 3 further includes apair of first hooks 356 extending from the first arm 352 and a pair ofsecond hooks 358 extending from the second arm 354. Each of the firsthooks 356 and second hooks 358 extend downward from the lid 304 towardthe body 302. Additionally, the latch assembly 350 includes a pair ofend latches 360; the first arm 352 includes a first end latch 360, andthe second arm 354 includes a second end latch 360. Like the hooks 356,358, the end latches 360 extend downward from their respective arms 352,354 toward the body 302.

To secure the lid 304 with respect to the body 302, each of the firstarm 352 and second arm 354 pivots down into place along the outer edge303 of the lid 304. When the arms 352, 354 are in position against thelid 304, the hooks 356, 358 engage the sides 302 c, 302 d of the body302 and the end latches 360 engage the ends 302 a, 302 b of the body302. More particularly, one first hook 356 releasably attaches to afirst side catch 364 on the first side 302 c of the body 302 and theother first hook 356 releasably attaches to another first side catch 36r on the second side 302 d of the body 302 to compress the first arm 352against the lid 304. To compress the second arm 354 against the lid 304,one second hook 358 releasably attaches to a second side catch 366 onthe first side 302 c of the body 302 and the other second hook 358releasably attaches to another second side catch 366 on the second side302 d of the body 302. Further, the first end latch 360 engages a firstend catch 368 on the first end 302 a of the body 302. Similarly, thesecond end latch 360 extends from the second arm 354 to the body 302 andengages a second end catch 368 on the second end 302 b of the body 302.

It will be appreciated from FIG. 3 that each of the end latches 360includes at least one element that is pivotable or rotatable withrespect to the respective first arm 352 or second arm 354 to engage andto disengage from the body 302. For example, a support 370 may beattached to each arm 352, 354, and a pin 372 may extend through each endlatch 360 to pin the latch to its respective support 370. As such, therespective end latch 360 is secured to its support 370 but can pivot orrotate about its pin 372. By grasping the end latch 360 and pivoting orrotating the end latch 360 with respect to its arm 352, 354, a user candisengage the respective end latch 360 from its respective end catch 368or engage the end latch 360 with its end catch 368.

As shown in the embodiment of FIG. 3, the lid 304 defines a recess 378around the outer edge 303 of the lid 304. The recess 378 has a shapecomplementary to both the first arm 352 and the second arm 354 forreceipt of the arms 352, 354. Each of the first arm 352 and the secondarm 354 pivots into the recess 378 and the end latches 360 and hooks356, 358 engage their respective catches to compress the lid 304 betweenthe first and second arms 352, 354 and the body 302.

Further, similar to the embodiment of FIGS. 1 and 2, in the embodimentof FIG. 3, the first arm 352 comprises a first segment 352 a, a secondsegment 352 b, and a third segment 352 c. An end 374 of each of thefirst and third segments 352 a, 352 c of the first arm 352 is secured tothe lid 304 near a longitudinal midline L_(M) of the lid 304. The firstarm 352 pivots about the ends 374. Moreover, the second arm 354comprises a first segment 354 a, a second segment 354 b, and a thirdsegment 354 c such that the second arm 354 is a mirror image of thefirst arm 352. An end 376 of each of the first and third segments 354 a,354 c of the second arm 354 is secured to the lid 304 near thelongitudinal midline L_(M) of the lid 304, and the second arm 354 pivotsabout the ends 376.

As shown in the embodiments of FIGS. 1-3, the end latches 330, 360extend from the respective first arm 322, 352 or second arm 324, 354,which is attached the lid 304, to an end catch 338, 368 on the body 302.However, in alternative embodiments, rather than being attached to thefirst arms 322, 352 and second arms 324, 254 of the lid 304, the endlatches 330, 360 could be attached to the body 302, e.g., using pins342, 372 such that the latches 330, 360 pivot with respect to the body302. In such alternative embodiments, the first end latches 330, 360would pivot upward from the body 302 toward the lid 304 and catch on thefirst arm 322, 352, either in a first end catch 338 defined in the firstarm 322, 352 or by fitting partially around or over the first arm 322,352. Similarly, the second end latches 330, 360 would pivot upward fromthe body 302 toward the lid 304 and catch on the second arm 324, 354,either in an end catch 338, 368 defined in the second arm 324, 354 or byfitting partially around or over the second arm 324, 354. Of course, inalternative embodiments, the first hooks 326, 356 and second hooks 328,358 also could be reversed such that they extend from the body 302 tothe lid 304, i.e., to the first arm 322, 352 and second arm 324, 354 ofthe lid 304. Other alternative configurations may be utilized as well.

It will be appreciated that the picnic basket-style closures describedwith respect to FIGS. 1-3 provide a more even pressure distributionalong the gasket 310 than typical sterilization containers, whichgenerally include one latch on each end of the container. That is, themultiple latches 330, 360 and hooks 326, 328, 356, 358 spaced about theentire perimeter of the sterilization container 300 provide several morelocations than typical containers where force is applied to keep the lid304 secured to the body 302. Further, the arms 322, 324, 352, 354 helpdistribute the pressure or force applied by the hooks 326, 328, 356, 358and latches 330, 360 to more evenly compress the gasket 310 between thelid 304 and body 302. A more evenly distributed force or pressure on thegasket 310 provides a better seal, helping to prevent the ingress ofcontaminants to the container interior 306, e.g., by resisting loss ofthe seal over time. For instance, with additional latches and hooks andarms that distribute the sealing pressure as described with respect tothe exemplary embodiments, the seal can be maintained even if one ormore latches or hooks loosen (or apply less force) over time. Of course,other advantages and benefits also may be realized from the closuremechanisms described with respect to FIGS. 1-3.

Referring still to FIGS. 1-3, as well as to FIGS. 4 and 5, in theillustrated exemplary embodiments, the sterilization container 300includes a gasket channel 380 that extends around the perimeter of thelid 304. The gasket channel 380 includes an inner segment 382, a lateralsegment 384, and an outer segment 386, and a channel or groove isdefined between the inner segment 382 and outer segment 386, with thelateral segment 384 forming the vertical boundary of the channel orgroove. The gasket 310 extends within the channel or groove of thegasket channel 380. In alternative embodiments, the gasket channel 380,with the gasket 310 positioned therein, could extend around theperimeter of the open top portion 308 of the body 302 rather than aroundthe lid 304. In any event, the gasket channel 380 and gasket 310 arearranged such that the gasket 310 lines the interface between the body302 and lid 304 of the container 300 to seal the container interior 306against the ingress of contaminants when the lid 304 is secured to thebody 302. For example, either the rim of the body 302 is received withinthe gasket channel 380 included with the lid 304 or the rim of the lid304 is received within the gasket channel 380 included with the body 302to compress the gasket 310 and seal the container 300 when the latches330, 360 and hooks 326, 328, 356, 358 secure the lid 304 to the body 302as described with respect to FIGS. 1-3.

In an exemplary embodiment, the gasket channel 380 is transparent suchthat the gasket 310 within the gasket channel 380 is visible to a userof the container 300. The transparent gasket channel 380 may be formedfrom a high temperature resistant material, such as Rader)polyphenylsulfone (PPSU). As described herein with respect to varioussterilization container embodiments, the gasket 310 may be the sealindicator 316 having a first indicator state and a second indicatorstate, i.e., the gasket 310 is configured to display a first indicium310 a when the container 300 is in a first, unsealed state and a secondindicium 310 b when the container 300 is in a second, sealed state.Because the gasket channel 380 is transparent, it provides a window forviewing the gasket 310 and the first and second indicia 310 a, 310 bthus are visible to the user through the gasket channel 380. Inexemplary embodiments, the first indicium 310 a is a first color or hueand the second indicium 310 b is a second color or hue. The first andsecond colors/hues may be contrasting or complementary colors, e.g., thefirst and second colors/hues may be selected such that there is a highcontrast between the colors/hues (e.g., to enable clear differentiationbetween the first indicium 310 a and second indicium 310 b) and/orbetween the colors/hues and the sterilization container 300, and/or thecolors/hues may be selected to reinforce the signal communicated by thecolor or hue. For instance, in an exemplary embodiment, the first coloris red to indicate the container 300 is unsealed (i.e., contaminantscould enter the container 300 and reach any articles in the interior306), and the second color is green to indicate the container 300 issealed (i.e., contaminants cannot enter the container 300 and anyarticles in the container 300 would remain sterile after sterilization).Thus, the seal indicator provided by the gasket 310 is configured todisplay the first color when the container 300 is unsealed and thesecond color when the container 300 is sealed, such that the gasket 310indicates a change in the seal state of the container 300 through achange in color. As described in more detail herein, in otherembodiments, the gasket 310 may utilize other features for indicatingthe seal state of the container 300 or the integrity of the gasket 310,e.g., other binary visual indicia such as patterns, images, and/orwords; other visual state changes such as changes in position, shape,and/or size; and/or auditory or other non-visual indicators.

FIGS. 4 and 5 depict the seal indicator features of the gasket 310 ingreater detail, according to an exemplary embodiment of the presentsubject matter. As shown in FIGS. 4 and 5, the gasket comprises, alongthe vertical direction V, a top portion 388, a middle portion 390, and abottom portion 392. At least one of the top portion 388 and the bottomportion 392 include the second indicium 310 b, and the middle portion390 includes the first indicium 310 a. Accordingly, the middle portion390 and the first indicium 310 a are visible to the user in the unsealedstate, i.e., when the gasket 310 is not compressed to seal the container300. The middle portion 390 is compressible such that the top portion388 meets the bottom portion 392 when the gasket 310 is compressed inthe sealed state and only the second indicium 310 b is visible to theuser, thereby indicating the container 300 is sealed. More particularly,the gasket 310 is notched or has a generally hourglass cross-sectionalshape such that the gasket 310 is thinner in the middle portion 390 thanin the top portion 388 or bottom portion 392. Further, the gasket 310may be formed from a compressible or deformable material. Accordingly,when the lid 304 is positioned on the body 302 and a generally downwardforce is applied to the lid 304, the top portion 388 of the gasket 310is forced toward the bottom portion 392 of the gasket 310, with themiddle portion 390 compressed between the top and bottom portions 388,392. As illustrated in FIGS. 4 and 5, at least the top portion 388includes a flange 394, which extends downward toward the bottom portion392. When the lid 304 is not secured to the body 302 as shown in FIG. 4,the flange 394 at least does not extend the entire height of the middleportion 390 such that the middle portion 390 and the first indicium 310a are visible to the user through the outer segment 386 of the gasketchannel 380. However, referring to FIG. 5, when the lid 304 is securedto the body 302, e.g., by attaching the hooks 326 to the side catches334 to latch the first arm 322 in place within the groove 348, theflange 394 extends between the compressed middle portion 390 and theouter segment 386 over the entire height of the compressed middleportion 390 such that only the second indicium 310 b, which is carriedor embodied by the top and bottom portions 388, 392, is visible to theuser through the outer segment 386 of the gasket channel 380. Thus, thegasket 310, when functioning as a seal as well as the seal indicator316, is collapsible when compressed to transition from displaying boththe first indicium 310 a and the second indicium 310 b (when the gasket310 is uncompressed and the container 300 is unsealed) to displayingonly the second indicium 310 b (when the gasket 310 is compressed andthe container 300 is sealed).

Of course, in some embodiments, the gasket channel 380 may includefeatures, such as a mask or other opaque material, such that only thefirst indicium 310 a is visible when the gasket 310 is not compressed.Further, in some embodiments, only the outer segment 386 of the gasketchannel 380 may be fully or partially transparent, i.e., the inner andlateral segments 382, 384 need not be transparent because a user cannotlook through the inner and lateral segments 382, 384 to view the gasket310. Moreover, the gasket channel 380 or the outer segment 386 may betransparent along the entire perimeter of the container 300 such thatthe gasket 310 is visible along the entire container perimeter and,thus, is a continuous indicator along the perimeter. However, in otherembodiments, the gasket channel 380 or the outer segment 386 may betransparent only in certain locations along the perimeter, e.g., in onelocation on each end and side of the container 300, such that the gasket310, and thereby the indicator 316, is visible only at those certainlocations. In still other embodiments, the seal indicator 316 may beseparate from the gasket 310 but may be configured similarly to thegasket seal indicator described above.

Referring still to FIGS. 4 and 5, in other embodiments, the seal stateof the container 300 may be indicated by state change of the sealindicator 316 that relies on an interaction between the gasket 310 andthe gasket channel 380. As previously described, at least the outersegment 386 of the gasket channel 380 is formed from a transparentmaterial such that the gasket 310 is visible through the outer segment386. The flange 394 of the top portion 388 of the gasket 310 may beconfigured to contact an inner surface 396 of the outer segment 386 whenthe lid 304 is secured to the body 302 and the gasket 310 issufficiently compressed to seal the interior 306. When the flange 394contacts the inner surface 396, there is a visible change at the gasketchannel 380. For example, the gasket 310 may be yellow and thetransparent outer segment 386 may be tinted blue such that when theyellow flange 394 contacts the transparent blue outer segment 386, agreen stripe (or other marking) is visible at the gasket channel 380. Ofcourse, other color combinations may be used as well. Further, thegasket 310 may be spaced from the outer segment 386 such that it is notclearly visible when uncompressed, but when the flange 394 contacts theouter segment inner surface 396, a stripe (or other marking) is visibleat the gasket channel 380. Other visual state changes, such as changesin pattern, shape, color, and size as described herein, may be used aswell. Accordingly, in such embodiments, the first indicator state iswhen the flange 394 is not in contact with the outer segment innersurface 396, which is signaled by any appropriate visual state of theseal indicator 316 as described herein, and the second indicator stateis when the flange is in contact with the outer segment inner surface396, which is signaled by any appropriate visual state of the sealindicator 316 as described herein that is different from the firstindicator state.

Referring now to FIGS. 6 and 7, another sterilization container with adifferent closure mechanism will be described, according to an exemplaryembodiment of the present subject matter. Like the sterilizationcontainers 300 described with respect to FIGS. 1-3, the exemplarysterilization container 400 of FIGS. 6 and 7 includes multiple latchesfor applying force to the container gasket at more locations thantypical sterilization containers, which helps provide a better sealbetween the container lid and body. More particularly, FIG. 6 provides aperspective view of the sterilization container 400 in a closedconfiguration, and FIG. 7 provides an exploded perspective view of thesterilization container 400. The depicted sterilization container 400comprises a body 402 and a cover or lid 404. The body 402 and lid 404together define an interior 406 of the sterilization container 400. Oneor more articles, e.g., clamps, scalpel blade handles, retractors,forceps, scissors, surgeon's towels, basins, and like surgical devices,instruments, or supplies, may be placed in the interior 406 of thecontainer 400 for sterilization such that the article(s) may be reusedin another procedure. It will be appreciated that the sterilizationcontainer 400 may generally have the form of a parallelepipedal boxshape as shown in FIGS. 6 and 7, and the container 400 may have anyappropriate size for containing the article(s) to be sterilized.

As shown in FIG. 6, to sterilize the article(s) in the containerinterior 406, and to maintain the sterility of such article(s) aftersterilization, the lid 404 may be secured to the body 402 such that thecontainer 400 is sealed against an ingress of contaminants. Morespecifically, the body 402 includes an open top portion 408 (FIG. 7),but when the lid 404 is secured to the body 402 as shown in FIG. 6, thelid 404 covers the open top portion 408 of the body 402 and a gasket 410is compressed between the lid 404 and body 402 to seal the container 400against the ingress of contaminants, as described in greater detailherein.

As shown in FIGS. 6 and 7, the lid 404 is retained on the body 402 byone or more latch assemblies 412. The latch assemblies 412 form aclosure mechanism for securing the lid 404 to the body 402 and sealingthe container interior 406, and the latch assemblies 412 are describedin greater detail herein. Further, the container 400 includes one ormore handles 414 for lifting, carrying, or otherwise handling thecontainer 400. For example, a first handle 414 may be attached to afirst end 402 a of the body 402, and a second handle 414 may be attachedto a second end 402 b of the body 402, where the second end 402 b isopposite the first end 402 a. In other embodiments, a first handle 414may be attached to a first side 402 c of the body 402, and a secondhandle 414 may be attached to a second side 402 d of the body 402, wherethe second side 402 d is opposite the first side 402 c and the first andsecond sides 402 c, 402 d extend between the first and second ends 402a, 402 b. Other configurations and/or placements of one or more handles414 may be used as well.

As further depicted in FIGS. 6 and 7, the container 400 may include avisual seal indicator 416 that provides a visual indication of a sealstate of the sterilization container 400. For instance, the sealindicator 416 has a first indicator state and a second indicator state.In the first indicator state, the seal indicator 416 indicates to a userof the container 400 that the container 400 is in a first, unsealedstate, where the container 400 is not sealed against the ingress ofcontaminants (i.e., contaminants could enter the container 400). In thesecond indicator state, the seal indicator 416 indicates to the userthat the container 400 is in a second, sealed state, where the container400 is sealed against the ingress of contaminants (i.e., contaminantscannot enter the container 400). That is, the seal indicator 416 is abinary indicator of the integrity of the seal between the body 402 andlid 404 of the container 400, e.g., the indicator 416 indicates when theseal is established and when the seal is broken or otherwise comprised.As described herein, the seal indicator 416 is unaffected by thesterilization modality to which the container 400 is subjected tosterilize the articles within the container 400. The seal indicator 416is described in greater detail herein.

Moreover, as shown in FIG. 6, in some embodiments the lid 404 definesone or more vents 418 in a top surface 405 of the lid 404. In otherembodiments of the lid 404, the lid 404 does not define vents 418 in thetop surface 405, but the vent(s) 418 are defined elsewhere in thecontainer 400, e.g., in one or more side surfaces 407 of the lid 404that are generally orthogonal to the top surface 405, in the body 402,or in both the lid 404 and the body 402. The vent(s) 418 permit fluids,such as air, steam, and chemical sterilization agents and/or othersterilants, to pass through the lid 404 and into the interior 406 of thesterilization container 400, e.g., to sterilize the contents of thecontainer 400, as well as to pass from the interior 406 to an exteriorenvironment, e.g., to help the contents of the container 400 dry after asterilization process.

A filter 420 is positioned within the sterilization container 400adjacent the vent(s) 418 to prevent contaminants from entering theinterior 406. For example, the filter 420 may be a sheet of materialthat extends over the open top portion 408 of the body 402 such that thefilter is positioned between the lid 404 and the container interior 406.Another example is illustrated in FIG. 7, where a filter 420, configuredas a sheet of material, is disposed adjacent each of two sets of vents418, i.e., two filters 420 are included in the container 400, as well asa filter retainer or cover 421 on the opposite side of the filters 420from the lid 404, e.g., to keep the filters 420 in position with respectto the vents 418. However, the filter(s) 420 need not be configured as asheet but may have any suitable configuration or construction. Further,the filter(s) 420 can be made from a number of materials, such as amaterial from one of two main classes, reusables and disposables, whichare described above with respect to FIGS. 1-3 in greater detail.Whatever materials are chosen, the resultant filter material must becompatible with the particular sterilization technique being used andmust also provide both strength and barrier properties to maintain thesterile nature of the contents of the sterilization container 400 untiluse. In some embodiments, the lid 404 may define a window through whichthe filter 420 or filters 420 are visible to a user of the container400, and the filter may also define a window, formed from a transparentbreathable film or the like that still provides a barrier againstcontaminants, such that the user can see through the filter(s) 420 andinto the interior 406 of the container 400 (e.g., in embodiments withoutfilter retainer or cover 421 or in which a window also is defined in thecover 421) such that the user can view any articles, other indicators,or the like within the container 400 as described herein. However, inother embodiments, the filter(s) 420 may be made from a translucent oropaque material, such as, e.g., an SMS material, polytetrafluoroethylene(PTFE), paper, or the like. For example, polyolefin-based fibers andtheir resultant nonwovens are particularly well-suited for theproduction of a flexible filter 420, and a polypropylene spunbondednonwoven can be used to impart strength characteristics to the filter420. In some embodiments, the filter 420 may be made from laminates suchas a laminate of spunbonded and meltblown or spunbonded, meltblown,spunbonded (SMS) to impart both strength and barrier properties to thefilter. SMS materials are described above in greater detail. In anexemplary embodiment, the filter 420 or filters 420 are made from an SMSmaterial, but the filter(s) 420 also may be made from other suitablematerials.

As previously stated, the sterilization container 400 includes latchassemblies 412 for securing the lid 404 to the body 402 and ensuring thegasket 410 is properly compressed to seal the container interior 406against the ingress of contaminants. In the exemplary embodiment ofFIGS. 6 and 7, the sterilization container 400 includes four latchassemblies 412, one at each end 402 a, 402 b and side 402 c, 402 d ofthe body 402. In other embodiments, the sterilization container 400includes any number greater than two of latch assemblies 412.

As shown in the depicted exemplary embodiment, each latch assembly 412comprises a first latch member 422, a second latch member 424, a catch426, a pair of pin supports 428, and a pair of pins 430. The first latchmember 422 is attached or connected to the second latch member 424 suchthat the first latch member 422 is in operable communication with thesecond latch member 424 via the pins 430. More particularly, a first pin430 extends through a first side 432 of the first latch member 422 andinto a first side 434 of the second latch member 424, and a second pin430 extends through a second side 436 of the first latch member 422 andinto a second side 438 of the second latch member 424. Each pin 430 alsoextends within a pin support 428, which is attached to the body 402,thereby securing the first and second latch members 422, 424 to thecontainer body 402.

A user manipulates the first latch member 422 to pivot the second latchmember 424 into and out of the catch 426 to latch and unlatch the lid404 with respect to the body 402. For example, from the closed positionshown in FIG. 6, a user may grasp the first latch member 422 and pivotor rotate the first latch member 422 upward to loosen or “pop” thesecond latch member 424 from the catch 426, which is defined in the lid404 in the depicted embodiment. Once all four second latch members 424are loosened with respect to their catches 426, the lid 404 is no longersecured to the body 402 and the lid 404 may be removed therefrom. Tosecure the lid 404 with respect to the body 402, a first end 440 of eachsecond latch member 424 is positioned at its respective catch 426. Whenthe user pushes on a first latch member 422, the first latch member 422pivots or rotates downward, pulling the associated second latch member424 into engagement with its catch 426. When all four first latchmembers 422 are pivoted or rotated downward against their respectivebody end 402 a, 402 b or side 402 c, 402 d, the lid 404 is secured withrespect to the body 402, and the gasket 420 is compressed to seal theinterior 406 against the ingress of contaminants. It will be appreciatedthat each of the first and second latch members 422, 424 pivots orrotates about the pins 430 that attach or connect the respective latchmembers 422, 424.

Although described herein as secured to the container body 402 andengaging a catch 426 on the lid 404, in other embodiments, the latchassemblies 412 may be reversed. That is, the first and second latchmembers 422, 424 may be secured (via pins 430 and pin supports 428 oranother suitable mechanism) to the lid 404. In such embodiments, thecatch 426 is defined or included on the body 402, and the second latchmember 424 pivots or rotates downward to engage the catch 426, with thefirst latch member 422 pivoting or rotating upward to secure the secondlatch member 424 in the catch 426, and the first latch member 422 pivotsor rotates downward to loosen the second latch member 424 from the catch426.

The visual seal indicator 416 of the sterilization container 400 may beconfigured as any of the seal indicators described herein. For example,the seal indicator 416 may be configured as a plunger-type indicatorassembly, such as one of indicator assemblies 40, 130, or 280, or as adeformable gasket-type indicator assembly, such as indicators 20 or 316.No matter its configuration, the seal indicator 416 provides a visualindication of a seal state of the sterilization container 400. Forinstance, the seal indicator 416 indicates to a user of the container400 whether the container 400 is in a first, unsealed state, where thecontainer 400 is not sealed against an ingress of contaminants (i.e.,contaminants could enter the container 400), or a second, sealed state,where the container 400 is sealed against the ingress of contaminants(i.e., contaminants cannot enter the container 400). That is, the sealindicator 416 is a binary indicator of the integrity of the seal betweenthe body 402 and lid 404 of the container 400, e.g., the indicator 416indicates when the seal is established and when the seal is broken orotherwise compromised. More particularly, the seal indicator 416 has afirst indicator state, in which the seal indicator 416 displays a firstindicium to indicate to a user that the container is in its unsealedstate, and a second indicator state, in which the seal indicator 416displays a second indicium to indicate to the user that the container isin its sealed state. The seal indicator 416 is visible to a user of thecontainer 400 from the exterior of the container 400 to signal to theuser whether the container is sealed or unsealed. A change in state,i.e., from the first indicator state to the second indicator state orfrom the second indicator state to the first indicator state, may beachieved by a change in color, shape, size, position, etc. of the sealindicator 416 to signal the container 400 has transitioned from itsunsealed state to its sealed state or from its sealed state to itsunsealed state.

Accordingly, the sterilization container 400 described with respect toFIGS. 6 and 7 provides improved sealing between the lid 404 and body402, as well as an indication of the state of the seal, i.e., of theintegrity of the seal. For instance, by providing at least one latchassembly 412 on each end 402 a, 402 b and side 402 c, 402 d, more forceor pressure is applied to the container gasket 410 to ensure a good sealbetween the body 402 and lid 404. Further, the latch assemblies 412 maybe sized, shaped, and positioned to maximize their effectiveness inapplying force or pressure on the gasket 410. That is, the latchassemblies 412, particularly the second latch members 424, may beconfigured to apply force or pressure to the gasket 410 at a certainlocation, over a minimum length, etc. to more evenly distribute theforce or pressure applied to the gasket 410, to apply a sufficientsealing force to the gasket 410, etc. Moreover, the seal indicator 416may be selected and positioned to reliably indicate to a user of thecontainer 400 whether the interior 406 of the container 400 is sealedagainst the ingress of contaminants. Of course, other benefits andadvantages also may be realized from the subject matter discussed withrespect to FIGS. 6 and 7.

Turning now to FIG. 8, in some embodiments of sterilization containers,the seal may have a maze configuration. That is, a tortuous path isformed from the container interior to the container exterior at theinterface between the container lid and container body, e.g., todecrease the likelihood that contaminants will enter the interior of thecontainer. For example, as described with respect to FIG. 8, thesterilization container 400 described with respect to FIGS. 6 and 7 mayinclude a maze seal 450. A portion of a latch assembly 412 isillustrated in FIG. 8; the first latch member 422 is omitted forclarity.

As shown in FIG. 8, a body interface feature 452 is provided along theupper perimeter of the body 402, i.e., along a rim 409 at the open topportion 408 of the body 402. A lid interface feature 454 is providedalong the outer edge 403 of the lid 404. Although shown as separatepieces attached to the body 402 and lid 404, in other embodiments, thebody interface feature 452 may be integral with the body 402 and the lidinterface feature 454 may be integral with the lid 404. For example, thebody interface feature 452 and the body 402 may be formed as a singlepiece, and the lid interface feature 454 and the lid 404 may be formedas a single piece.

Each interface feature 452, 454 defines a series of channels such thatthe body interface feature 452 meshes with the lid interface feature 454to form a tortuous path from the environment external to the container400 to the container interior 406. More particularly, the body interfacefeature 452 includes body channel segments 456; in the depictedembodiment, the body interface feature 452 includes three body channelsegments: first segment 456 a, second segment 456 b, and third segment456 c. Further, body channels 458 are defined between the body channelsegments 456. A first body channel 458 a is defined between the firstbody channel segment 456 a and the second body channel segment 456 b,and a second body channel 458 b is defined between the second bodychannel segment 456 b and the third body channel segment 456 c.Similarly, the lid interface feature 454 includes lid channel segments460, and in the illustrated embodiment, the lid interface feature 454includes four lid channel segments: first segment 460 a, second segment460 b, third segment 460 c, and fourth segment 460 d. The first andfourth lid channel segments 460 a, 460 d flank the body interfacefeature 452, such that the body interface feature 452 fits within thelid interface feature 454. Moreover, lid channels 462 are definedbetween the lid channel segments 460. A first lid channel 462 a isdefined between the first lid channel segment 460 a and the second lidchannel segment 460 b, a second lid channel 462 b is defined between thesecond lid channel segment 460 b and the third lid channel segment 460c, and a third lid channel is defined between the third channel segment460 c and the fourth lid channel segment 460 d.

As shown in FIG. 8, the body channel segments 456 fit within the lidchannels 462, and the second and third lid channel segments 460 b, 460 cfit within the body channels 458, with the first and fourth lid channelsegments 460 a, 460 d extending along an inner surface 452 a and anouter surface 452 b, respectively, of the body interface feature 452.Further, the first lid channel segment 460 a is longer than the otherlid channel segments 460, extending downward along the inner surface 452a of the body interface feature 452 beyond the bottom of the bodychannels 458.

As further illustrated in FIG. 8, a gasket 464 is positioned at thebottom of each lid channel 462 such that the gaskets 464 may becompressed between the body 402 and lid 404 of the container 400 whenthe lid 404 is secured to the body 402. Together with the multiplechannel segments 456, 460, channels 458, 462, and lengthened inner orfirst lid channel segment 460 a, the gaskets 464 help preventcontaminants from the external environment from entering the containerinterior 406. More particularly, the interface between the lid 404 andthe body 402 provides a location for contaminants to enter the containerinterior 406 after the container contents have been sterilized andthereby compromise the sterility of the articles in the container 400.The series of channel segments 456, 460 received in channels 458, 462,or the intermeshing of the body interface feature 452 with the lidinterface feature 454, creates a tortuous path at the body-lip interfacefor contaminants to traverse to enter the container interior 406, thusdiscouraging contaminants from entering the interior 406. Further, theseries of gaskets 464 help stop contaminants from advancing through themaze seal 450 along the tortuous path, e.g., by blocking thecontaminants on the exterior side of the container 400. Accordingly,while either the intermeshed interface features 452, 454 or the gaskets464 would, on their own, help prevent contaminants from advancing intothe interior 406, the combination of the intermeshed interface features454, 454 and gaskets 464 provide enhanced protection and/or layers ofprotection such that the container interior 406 may be protected againstcontamination even if one or more layers of protection are breached.

It will be appreciated that the maze seal 450 may have otherconfigurations as well. For example, a different number of body channels458 and lid channels 460 may be defined by a different number of bodychannel segments 456 and lid channel segments 460. As another example,the lid interface feature 454 may be received within the body interfacefeature 452, where the body interface feature 452 includes one morechannel segment 456 than the lid interface feature 454 such that a bodychannel segment 456 extends along the inner and outer surfaces of thelid interface feature 454. Additionally, in such embodiments, the bodyinterface feature 452 would define one more channel 458 than the lidinterface feature 454. Further, the gaskets 464 may be positioned in thebottom of the body channels 458 rather than in the bottom of the lidchannels 462 as shown in FIG. 8. Still further, the channels 458, 462and gaskets 464 may have a different cross-sectional shape than asillustrated in FIG. 8. For instance, although shown with generally roundor circular cross-sectional shapes, the cross-sections may be generallysquare or any other suitable shape.

Additionally, the maze seal 450 may be used with any appropriatesterilization container and, thus, may be used in conjunction with aseparate seal indicator. However, in some embodiments, the maze seal 450also may incorporate a visual seal indicator 416. For example, asdescribed above with respect to some embodiments of the visual sealindicator 316, at least the lid interface feature 454 may be formed froma transparent material, such as high temperature resistant Rader) PPSU,and the gaskets 464 may be visible through the lid interface feature454. More particularly, the gaskets 464 contact an inner surface 466 ofthe lid interface feature 454 when the lid 404 is secured to the body402 and the gaskets 464 are sufficiently compressed to seal thecontainer interior 406. When the gaskets 464 contact the inner surface466, there is a visible change at the lid interface feature 454. Forexample, the gaskets 464 may be yellow and the transparent lid interfacefeature 454 may be tinted blue such that when the yellow gaskets 464contact the transparent blue lid interface feature 454, green stripes(or other markings) that extend around the perimeter of the lid 404 arevisible at the lid interface feature 454. Thus, the visual sealindicator provided by the maze seal 450 is visible from all sides of thecontainer 400. Of course, other color combinations or other visual statechanges, such as changes in pattern, shape, and/or size as describedherein, may be used as well. Accordingly, the maze seal 450 may providebe an indicator of the seal state of the container 400, where the firstindicator state is when the gaskets 464 are not in contact with the lidinterface feature 454, which is signaled by any appropriate visual stateof the seal indicator 416 as described herein (e.g., the lid interfacefeature 454 appears only blue). The second indicator state is when thegaskets 464 are in contact with the lid interface feature 454, which issignaled by any appropriate visual state of the seal indicator 416 asdescribed herein that is different from the first indicator state (e.g.,lid interface feature 454 appears blue with green stripes).

Accordingly, the maze seal 450 described with respect to FIG. 8 providesimproved sealing between the lid 404 and body 402, as well as anindication of the state of the seal, i.e., of the integrity of the sealbetween the body 402 and lid 404. For instance, by providingintermeshing segments and gaskets along the interface between the body402 and lid 400 of the container 400, the maze seal 450 creates atortuous path that contaminants must traverse to enter the containerinterior 406, thereby reducing the opportunity of contaminant breach (bybacteria or the like). Moreover, the maze seal 450 may be configured toinclude the seal indicator 416 to indicate to a user of the container400 whether the interior 406 of the container 400 is sealed against theingress of contaminants. However, the maze seal 450 also may be usedwith other sterilization container embodiments, including suchembodiments that provide other means for indicating the integrity of theseal between the container body and lid. Further, other benefits andadvantages also may be realized from the subject matter discussed withrespect to FIG. 8.

Turning now to FIGS. 9 through 12, another sterilization container 500will be described, according to an exemplary embodiment of the presentsubject matter. The sterilization container 500 comprises a body 502 anda lid or cover 504 that together define an interior 506 of thesterilization container 500. One or more articles, e.g., clamps, scalpelblade handles, retractors, forceps, scissors, surgeon's towels, basins,and like surgical devices, instruments, or supplies, may be placed inthe container interior 506 for sterilization such that the article(s)may be reused in another procedure. It will be appreciated that thesterilization container 500 may generally have the form of aparallelepipedal box shape as shown in FIGS. 9-12, and the container 500may have any appropriate size for containing the article(s) to besterilized. Further, it will be understood that the sterilizationcontainer 500, particularly the body 502, may be configured similarly tothe other exemplary sterilization containers described herein. However,the lid 504 and closure mechanism embody differences from othersdescribed herein.

As shown in FIG. 9, to sterilize the article(s) in the containerinterior 506, and to maintain the sterility of such article(s) aftersterilization, the lid 504 may be secured to the body 502 such that thecontainer 500 is sealed against an ingress of contaminants. Morespecifically, the body 502 includes an open top portion 508 (FIG. 10),but when the lid 504 is secured to the body 502 as shown in FIG. 9, thelid 504 covers the open top portion 508 of the body 502 and a gasket 510is compressed between the lid 504 and body 502 to seal the container 500against the ingress of contaminants, as described in greater detailherein.

As shown in FIGS. 9-12, the lid 504 is retained on the body 502 by oneor more latch assemblies 512. The latch assemblies 512 are described ingreater detail herein. Further, the container 500 includes one or morehandles 514 for lifting, carrying, or otherwise handling the container500. For example, a first handle 514 may be attached to a first end 502a of the body 502, and a second handle 514 may be attached to a secondend 502 b of the body 502, where the second end 502 b is opposite thefirst end 502 a. In other embodiments, a first handle 514 may beattached to a first side 502 c of the body 502, and a second handle 514may be attached to a second side 502 d of the body 502, where the secondside 502 d is opposite the first side 502 c and the first and secondsides 502 c, 502 d extend between the first and second ends 502 a, 502b. Other configurations and/or placements of one or more handles 514 maybe used as well.

As further depicted in FIGS. 9-12, the container 500 may include avisual seal indicator 516 that provides a visual indication of a sealstate of the sterilization container 500. For instance, the sealindicator 516 has a first indicator state and a second indicator state.In the first indicator state, the seal indicator 516 indicates to a userof the container 500 that the container 500 is in a first, unsealedstate, where the container 500 is not sealed against the ingress ofcontaminants (i.e., contaminants could enter the container 500). In thesecond indicator state, the seal indicator 516 indicates to the userthat the container 500 is in a second, sealed state, where the container500 is sealed against the ingress of contaminants (i.e., contaminantscannot enter the container 500). That is, the seal indicator 516 is abinary indicator of the integrity of the seal between the body 502 andlid 504 of the container 500, e.g., the indicator 516 indicates when theseal is established and when the seal is broken or otherwise comprised.As described herein, the seal indicator 516 is unaffected by thesterilization modality to which the container 500 is subjected tosterilize the articles within the container 500. The seal indicator 516is described in greater detail herein.

Moreover, as shown in FIGS. 9-12, the lid 504 and a filter 520 defineone or more vents 518 of the sterilization container 500. In otherembodiments of the container 500, the vent(s) 518 may be defined asshown in other embodiments, e.g., as openings 518 in a top surface 505of the lid 504; as openings 518 in one or more side surfaces 507 of thelid 504, where the side surfaces 507 are orthogonal to the top surface504; as openings 518 in the body 502; or as openings 518 in both the lid504 and the body 502. The vent(s) 518 and filter 520 permit fluids, suchas air, steam, and chemical sterilization agents and/or othersterilants, to pass through the lid 504 and into the interior 506 of thesterilization container 500, e.g., to sterilize the contents of thecontainer 500, as well as to pass from the interior 506 to an exteriorenvironment, e.g., to help the contents of the container 500 dry after asterilization process. As illustrated, for example, in FIG. 9, thefilter 520 is disposed between the lid 504 and the body 502 such thatthe lid 504 is spaced apart from the body 502 (except for the latchassemblies 512, as described in greater detail herein). As such, thefilter 520 is directly exposed to the environment external to thecontainer 500. That is, spacing the lid 504 from the body 502 createsspaces that define the vents 518, and the filter 520 is disposed withinthe spaces to provide a barrier between the external environment and thecontainer interior 506.

The filter 520 can be made from a number of materials, such as amaterial from one of two main classes, reusables and disposables, whichare described above with respect to FIGS. 1-3 in greater detail.Whatever materials are chosen, the resultant filter material must becompatible with the particular sterilization technique being used andmust also provide both strength and barrier properties to maintain thesterile nature of the contents of the sterilization container 500 untiluse. In some embodiments, the lid 504 may be transparent or may define awindow 519 through which a user of the sterilization container 500 canview the container interior 506 and, thus, the contents of the container500, such as any articles, indicators, or the like as described herein.The filter 520 adjacent the lid 504 likewise may define a window, formedfrom a transparent breathable film or the like that still provides abarrier against contaminants, such that the user can see through thefilter 520 and into the interior 506. However, in other embodiments, thefilter 520 may be made from a translucent or opaque material, such as,e.g., an SMS material, polytetrafluoroethylene (PTFE), paper, or thelike. For example, polyolefin-based fibers and their resultant nonwovensare particularly well-suited for the production of a flexible filter520, and a polypropylene spunbonded nonwoven can be used to impartstrength characteristics to the filter 520. In some embodiments, thefilter 520 may be made from laminates such as a laminate of spunbondedand meltblown or spunbonded, meltblown, spunbonded (SMS) to impart bothstrength and barrier properties to the filter. SMS materials aredescribed above in greater detail. In an exemplary embodiment, thefilter 520 is made from an SMS material, but the filter 520 also may bemade from other suitable materials.

Further, in the depicted exemplary embodiment, the gasket 510 and filter520 are integrally formed as a single piece component, which may bereferred to herein as a combination gasket/filter 522. A combinationgasket/filter 622 according to another exemplary embodiment of thepresent subject matter is described herein with respect to FIGS. 13-16.In some embodiments, the gasket 510 of the combination gasket/filter 522forms the outermost boundary of the combination gasket/filter 522. Insuch embodiments, the gasket portion 510 of the combinationgasket/filter 522 may be wider than typical sterilization containergaskets, and as shown in FIG. 10, the lip 509 (i.e., the portion of thebody 502 against which the gasket portion 510 rests) also may be widerthan normal. As such, the body 502 and the gasket portion 510 of thegasket/filter 522 have an increased contact area compared to typicalsterilization containers, thereby forming a more tortuous path forcontaminants to enter the container interior 506.

Further, because the combination gasket/filter 522 is formed as a singlepiece component, even when including a transparent film to form a windowinto the interior 506, and the gasket/filter 522 completely covers theopen top end 508 of the body 502 as shown in the figures, interfacesbetween mating parts can be minimized. For example, a combinationgasket/filter eliminates separate interfaces between the lid 504 andfilter 520 and the lid 504 and gasket 510. Minimizing the number ofinterfaces helps reduce the opportunity for contamination breach, i.e.,a breach of the seal by bacteria or other organisms or substances thatcould compromise the sterility and safety of the articles within thecontainer 500. Further, the combination gasket/filter 522 allows for asingle use gasket 510, which eliminates wear and tear to the gasket 510that arises from reusing the gasket in additional opening/closing cyclesand sterilization cycles. That is, it may be desirable for thegasket/filter 522 to be a disposable, single use component of thecontainer 500, e.g., to reduce the opportunity for seal breach due towear of the gasket 510. As illustrated in FIG. 10, in some embodimentsthe lid 504 also may be configured to be disposable, such that a new,single use lid and gasket/filter assembly is used with a reusable body502 each time the container 500 is used to sterilize one or morearticles. Moreover, the single piece gasket/filter 522 simplifiesassembly and use by a user of the container 500. For example, a singlepiece gasket/filter 522 is easier to assemble with the body 502 and lid504 than a separate gasket and one or more filters, which also couldrequire filter retainers or the like to hold them in position. Thus, thereduced number of parts helps simplify assembly of the container 500.Similarly, a single piece gasket/filter 522 is easier to remove thanmultiple pieces, thereby simplifying the opening of the container 500.

As previously stated, the sterilization container 500 includes latchassemblies 512 forming a closure mechanism for securing the lid 504 tothe body 502 and ensuring the gasket 510 is properly compressed to sealthe container interior 506 against the ingress of contaminants. In theexemplary embodiment of FIGS. 9-12, the sterilization container 500includes four latch assemblies 512, one at each end 502 a, 502 b andside 502 c, 502 d of the body 502. In other embodiments, thesterilization container 500 includes any suitable number of latchassemblies 512.

As shown in FIGS. 9-12, the latch assemblies 512 include a first endlatch assembly 512 a, a second end latch assembly 512 b, a first sidelatch assembly 512 c, and a second side latch assembly 512 d. Three ofthe four latch assemblies 512 are configured very similarly and, if notidentical, are nearly identical. The fourth latch assembly 512 issimilar but has one particular difference, a handle, which could beincorporated into any of the other latches 512. More particularly, eachlatch assembly 512 includes an arm 524 that extends downward from thelid 504 toward the container body 502. That is, a first arm 524 aextends downward from a first end 504 a of the lid 504, a second arm 524b extends downward from a second end 504 b of the lid 504, a third armextends downward from a first side 504 c of the lid 504, and a fourtharm extends downward from a second side 504 d of the lid 504. On eacharm 524, a projection 526 extends inward toward the container body 502from a distal end 524 a of the arm 524. Each projection 526 engages acatch 528, such as a lip 509 defined along the open top portion 508 ofthe body 502, to secure the lid 504 to the body 502. The first sidelatch assembly 512 c, which is the fourth, different latch assembly 512as shown in FIG. 9, also includes a handle 530 that is integrally formedwith the arm 524 of the first side latch assembly 512 c. As shown, forexample, in FIG. 12, the user may grasp the handle 530 to unlatch thelatch assemblies 512, first by disengaging the projection 526 of thefirst side latch assembly 512 c from its catch 528. Then, as the usercontinues to lift the lid 504 away from the body 502, the remainingprojections 526 are disengaged from their respective catches 528 toremove the lid 504 from the body 502. As illustrated in FIG. 12, the endlatch assemblies 512 a, 512 b, which are disposed between the side latchassemblies 512 c, 512 d, may be disengaged after the first side latchassembly 512 c, and the second side latch assembly 512 d, which isopposite the first side latch assembly 512 c, may be disengaged last.The handle 530 and arm 524 provide an area 532 for attaching or securinga label that, e.g., specifies the contents of the container 500, thedate and time of sterilization, and/or other pertinent information, or away to access such information, such as a radio-frequency identification(RFID) tag, a barcode, a matrix or two-dimensional barcode (or QuickResponse (QR) code), or other appropriate means for accessing suchinformation.

As depicted in the exemplary embodiment shown in FIGS. 9-12, the arm 524of each latch assembly 512 may extend along a majority of the respectivelid end 504 a, 504 b or lid side 504 c, 504 d from which the arm 524depends. More specifically, each arm 524 has a length such that the arm524 extends along the majority of the portion of the lid 504 from whichthe respective arm 524 depends. Each projection 526 may extend over thelength of the arm 524 on which the projection 526 is defined, or theprojection may extend along only a portion of the length of the arm 524on which the projection 526 is defined. Alternatively, each arm 524 maydefine a plurality of projections 526 along the length of the arm 524.As described herein with respect to other sterilization containerembodiments, the distribution of the latch assemblies 512 about theperimeter of the container 500, as well as the length of the arms 524,provides a more even pressure distribution along the gasket 510 thantypical sterilization containers, which generally include one latch oneach end of the container. That is, the multiple latch assemblies 512spaced about the perimeter of the sterilization container 500 provideseveral more locations than typical containers where force is applied tokeep the lid 504 secured to the body 502. Further, when the projections526 engage their catches 528, the arms 524 distribute the appliedpressure or force along their length, which helps more evenly compressthe gasket 510 between the lid 504 and body 502. A more evenlydistributed force or pressure on the gasket 510 provides a better seal,helping to prevent the ingress of contaminants to the container interior506, e.g., by resisting loss of the seal over time. For instance, withadditional latch assemblies 512 having arms 524 that distribute thesealing pressure, the seal can be maintained even if one or more latchassemblies 512 loosen (or apply less force) over time. Of course, otheradvantages and benefits also may be realized from the closure mechanismdescribed with respect to FIGS. 9-12.

As shown in the exemplary embodiment, the visual seal indicator 516 maybe incorporated into the filter 520. The seal indicator 516 may beconfigured similarly to the deformable gasket-type indicator assembliesdescribed herein, such as indicators 20 or 316, which extends around theperimeter of the container 500 and is visible from all sides of thecontainer 500, or the indicator 516 may have a different configuration.For example, the seal indicator 516 may be a compressible feature of thefilter 520 configured like the gasket seal indicator 316 of FIGS. 4 and5, comprising along the vertical direction V a top portion, a middleportion, and a bottom portion. The middle portion is compressible suchthat the top portion meets the bottom portion when the seal indicator516 is compressed in the sealed state, revealing an indicium of thesealed state as described in greater detail herein. When the sealindicator 516 is not compressed, e.g., when the lid 504 is not securedto the body 502, the middle portion is uncompressed and, thus, visibleto the user through the latch assemblies 512 and at the vents 518. Ofcourse, the seal indicator 516 may have other configurations as well,e.g., the seal indicator 516 may be formed from a compressible materialthat changes from one color to another when compressed, or the container500 may include a seal indicator that is configured as a plunger-typeindicator assembly, such as one of indicator assemblies 40, 130, or 280.

As previously stated, the seal indicator 516 provides a visualindication of the seal state of the sterilization container 500. Moreparticularly, the seal indicator 516 has a first indicator state thatindicates the unsealed container state and a second indicator state thatindicates the sealed container state. The seal indicator 516 is visibleto a user of the container 500 from the exterior of the container 300 tosignal to the user whether the container 500 is sealed or unsealed. Achange in state, i.e., from the first indicator state to the secondindicator state or from the second indicator state to the firstindicator state, may be achieved by a change in color, shape, size,position, etc. of the seal indicator 516 to signal the container 500 hastransitioned from its unsealed state to its sealed state or from itssealed state to its unsealed state. Thus, when the gasket 510 is notcompressed, or not fully compressed, such that the interior 506 is notsealed against the ingress of contaminants, the container 500 is in itsfirst, unsealed state and the seal indicator 516 is in its firstindicator state. Similarly, when the gasket 510 is fully compressed,such that the interior 506 is sealed against the ingress ofcontaminants, the container 500 is in its second, sealed state and theseal indicator 516 transitions from its first indicator state to itssecond indicator state. Other means for indicating the seal state of thecontainer 500 or the integrity of the gasket 510, e.g., auditory orother non-visual indicators, may be used as well.

As described with respect to other embodiments, the seal indicator 516is configured to display a first indicium 516 a in the first indicatorstate and is configured to display a second indicium 516 b in the secondindicator state. In an exemplary embodiment, the first indicium 516 a isa first color or hue and the second indicium 516 b is a second color orhue, and the first and second colors/hues may be selected such thatthere is a high contrast between the colors/hues and/or between thecolors/hues and the sterilization container 500, and/or the colors/huesmay be selected to reinforce the signal communicated by the color orhue. For example, in an exemplary embodiment, the first color is red toindicate the container 500 is unsealed (i.e., contaminants could enterthe container 500 and reach any articles in the interior 506), and thesecond color is green to indicate the container 500 is sealed (i.e.,contaminants cannot enter the container 500 and any articles in thecontainer 500 would remain sterile after sterilization). In anotherexemplary embodiment, in the first indicator state (when the container500 is unsealed), no separate indicium may be displayed or the firstindicium 516 a may be the same color as the filter media 520 of thecombination gasket/filter 522, e.g., the combination gasket/filter 522may be all one color as shown in FIGS. 10-12. In such embodiments, theseal indicator 516 displays the second indicium 516 b in the secondindicator state (when the container 500 is sealed), and the secondindicium 516 b may be a different color or hue from the filter media520, e.g., a high contrast color from the color of the filter media 520,as shown in FIGS. 9 and 11. Thus, the seal indicator 516 is configuredto display a first color or hue when the container 500 is unsealed and asecond color or hue when the container 500 is sealed, such that the sealindicator 516 indicates a change in the seal state of the container 500through a change in color. In other embodiments, other visual indicia,such as patterns, images, and/or words, may be used instead of or inconjunction with colors to indicate the container seal state and theintegrity of the gasket 510.

As depicted most clearly in FIGS. 9 and 10, the seal indicator 516extends about the entire perimeter of the filter 520 such that the sealindicator 516 is visible from the container exterior on all sides of thecontainer 500. That is, the seal indicator 516 is visible from each ofthe first end 502 a, the second end 502 b, the first side 502 c, and thesecond side 502 d of the body 502. Further, at least the arms 524 of thelatch assemblies 512 are formed from a transparent material, as shown inFIGS. 9-11, such that the seal indicator 516 is visible through the arms524. In some embodiments, the entire lid 504 may be formed from atransparent material such that the entire gasket/filter 522, includingthe seal indicator 516, is visible from the exterior of the container500, including through the top surface 505 of the lid 504.

Accordingly, the sterilization container 500 described with respect toFIGS. 9-12 provides improved sealing between the lid 504 and body 502,as well as a simple means for opening the container 500 and anindication of the state of the seal, i.e., of the integrity of the sealbetween the lid 504 and body 502. For instance, by providing at leastone latch assembly 512 on each end 502 a, 502 b and side 502 c, 502 d,more force or pressure is applied to the container gasket 510 to ensurea good seal between the body 502 and lid 504. Further, the latchassemblies 512 may be sized, shaped, and positioned to maximize theireffectiveness in applying force or pressure on the gasket 510. That is,the latch assemblies 512, particularly the arms 524, may be configuredto apply force or pressure to the gasket 510 at a certain location, overa minimum length, etc. to more evenly distribute the force or pressureapplied to the gasket 510, to apply a sufficient sealing force to thegasket 510, etc. Additionally, at least one latch assembly 512 includesa handle 530 for easily disengaging, e.g., with one hand as shown inFIG. 12, the latch assemblies 512 and opening the container 500.Moreover, the seal indicator 516 may be selected and positioned toreliably indicate to a user of the container 500 whether the interior506 of the container 500 is sealed against the ingress of contaminants.Of course, other benefits and advantages also may be realized from thesubject matter discussed with respect to FIGS. 9-12.

Turning now to FIGS. 13 through 16, another sterilization container 600will be described, according to an exemplary embodiment of the presentsubject matter. The sterilization container 600 comprises a body 602 anda lid or cover 604. As described herein, the body 602 and lid 604 orbody 602 and a combination gasket/filter 622 together define an interior606 of the sterilization container 600. One or more articles, e.g.,clamps, scalpel blade handles, retractors, forceps, scissors, surgeon'stowels, basins, and like surgical devices, instruments, or supplies, maybe placed in the container interior 606 for sterilization such that thearticle(s) may be reused in another procedure. It will be appreciatedthat the sterilization container 600 may generally have the form of aparallelepipedal box shape as shown in FIGS. 13-16, and the container600 may have any appropriate size for containing the article(s) to besterilized.

Referring particularly to FIG. 14, the container 600 includes a filter620 that comprises a gasket 610 for sealing the container interior 606against the ingress of contaminants. That is, the gasket 610 and filter620 are integrally formed as a single piece component, which may bereferred to herein as a combination gasket/filter 622. As shown in FIG.14, to sterilize the article(s) in the container interior 606, and tomaintain the sterility of such article(s) after sterilization, thecombination gasket/filter 622 may be secured to the body 602 such thatthe container 600 is sealed against an ingress of contaminants. Morespecifically, the body 602 includes an open top portion 608, but whenthe combination gasket/filter 622 is secured to the body 602 asillustrated in FIG. 13, the combination gasket/filter 622 covers theopen top portion 608 of the body 602 to close the interior 606 and thegasket 610 of the combination gasket/filter 622 is compressed againstthe body 602 to seal the container 600 against the ingress ofcontaminants, as described in greater detail herein. The lid 604 fitsover or around the combination gasket/filter 622, e.g., to provideadditional rigidity and/or stiffness to the combination gasket/filter622. Further, the lid 604 may protect the combination gasket/filter 622,e.g., at the corners, sides, and top edges of the gasket/filter 622, aswell as a top surface 624 by providing a surface for stacking anothersterilization container on top of the container 600 that is separatefrom the gasket/filter 622.

As shown in FIGS. 13-16, the combination gasket/filter 622 includes aplurality of gasket assemblies 612, which comprise the gasket 610. Thegasket assemblies 612, which form a closure mechanism for sealing thecontainer interior 606, are described in greater detail herein. Further,the container 600 includes one or more handles 614 for lifting,carrying, or otherwise handling the container 600. For example, a firsthandle 614 may be attached to a first end 602 a of the body 602, and asecond handle 614 may be attached to a second end 602 b of the body 602,where the second end 602 b is opposite the first end 602 a. In otherembodiments, a first handle 614 may be attached to a first side 602 c ofthe body 602, and a second handle 614 may be attached to a second side602 d of the body 602, where the second side 602 d is opposite the firstside 602 c and the first and second sides 602 c, 602 d extend betweenthe first and second ends 602 a, 602 b. Other configurations and/orplacements of one or more handles 614 may be used as well.

As further depicted in FIGS. 13-16, the container 600 may include avisual seal indicator 616 that provides a visual indication of a sealstate of the sterilization container 600. For instance, the sealindicator 616 has a first indicator state and a second indicator state.In the first indicator state, the seal indicator 616 indicates to a userof the container 600 that the container 600 is in a first, unsealedstate, where the container 600 is not sealed against the ingress ofcontaminants (i.e., contaminants could enter the container 600). In thesecond indicator state, the seal indicator 616 indicates to the userthat the container 600 is in a second, sealed state, where the container600 is sealed against the ingress of contaminants (i.e., contaminantscannot enter the container 600). That is, the seal indicator 616 is abinary indicator of the integrity of the seal between the body 602 andcombination gasket/filter 622, e.g., the indicator 616 indicates whenthe seal is established and when the seal is broken or otherwisecomprised. As described herein, the seal indicator 616 is unaffected bythe sterilization modality to which the container 600 is subjected tosterilize the articles within the container 600. The visual indicator616 is described in greater detail herein.

Moreover, as shown in FIGS. 13-16, the lid 604 defines one or more vents618 through which the combination gasket/filter 622 is exposed. Thevent(s) 618 and filter 620 of the gasket/filter 622 permit fluids, suchas air, steam, and chemical sterilization agents and/or othersterilants, to pass through the lid 604 and into the interior 606 of thesterilization container 600, e.g., to sterilize the contents of thecontainer 600, as well as to pass from the interior 606 to an exteriorenvironment, e.g., to help the contents of the container 600 dry after asterilization process. As illustrated, for example, in FIGS. 13 and 14,the filter 620 extends over the entire open top portion 608 of the body602 to provide a barrier between the external environment and thecontainer interior 606.

The filter 620 of the combination gasket/filter 622 can be made from anumber of materials, such as a material from one of two main classes,reusables and disposables, which are described above with respect toFIGS. 1-3 in greater detail. Whatever materials are chosen, theresultant filter material must be compatible with the particularsterilization technique being used and must also provide both strengthand barrier properties to maintain the sterile nature of the contents ofthe sterilization container 600 until use. As shown in FIGS. 13 and 14,the combination gasket/filter 622 defines a window 626 through which auser of the sterilization container 600 can view the container interior606. Further, the lid 604 defines a window 628 through which thegasket/filter window 626 is visible; the lid 604 may includecross-members 628 a across the window 628 to help provide rigidity andstability to the lid 604, e.g., when stacking sterilization container600 with another container, without blocking the view through the window628. The filter 620 may likewise define a window, formed from atransparent breathable film or the like that still provides a barrieragainst contaminants, such that the user can see through the filter 620and into the interior 606 to view any articles, other indicators, or thelike that are within the container 600. However, in other embodiments,the filter 620 may be made from a translucent or opaque material, suchas, e.g., an SMS material, polytetrafluoroethylene (PTFE), paper, or thelike. For example, polyolefin-based fibers and their resultant nonwovensare particularly well-suited for the production of a flexible filter620, and a polypropylene spunbonded nonwoven can be used to impartstrength characteristics to the filter 620. In some embodiments, thefilter 620 may be made from laminates such as a laminate of spunbondedand meltblown or spunbonded, meltblown, spunbonded (SMS) to impart bothstrength and barrier properties to the filter. SMS materials aredescribed above in greater detail. In an exemplary embodiment, thefilter 620 is made from an SMS material, but the filter 620 also may bemade from other suitable materials.

As described, the combination gasket/filter 622 is formed as a singlepiece component, even when including a window 626, and as shown in thefigures, the gasket/filter 622 completely covers the open top end 608 ofthe body 602, both of which minimize interfaces between mating parts.Minimizing the number of interfaces helps reduce the opportunity forcontamination breach, i.e., a breach of the seal by bacteria or otherorganisms or substances that could compromise the sterility and safetyof the articles within the container 600. Further, the combinationgasket/filter 622 allows for a single use gasket 610, which eliminateswear and tear to the gasket 610 that arises from reusing the gasket inadditional opening/closing cycles and sterilization cycles. That is, itmay be desirable for the gasket/filter 622 to be a disposable, singleuse component of the container 600, e.g., to reduce the opportunity forseal breach due to wear of the gasket 610. Moreover, the single piecegasket/filter 622 simplifies assembly and use by a user of the container600. For example, a single piece gasket/filter 622 is easier to assemblewith the body 602 and lid 604 than a separate gasket and one or morefilters, which also could require filter retainers or the like to holdthem in position. Thus, the reduced number of parts helps simplifyassembly of the container 600. Similarly, a single piece gasket/filter622 is easier to remove than multiple pieces, thereby simplifying theopening of the container 600.

As previously described, the gasket 610 of the combination gasket/filter622 is part of a gasket assembly 612, which also includes the sealindicator 616, and a plurality of gasket assemblies 612 are providedwith the gasket/filter 622 depicted in the exemplary embodiment. Moreparticularly, each gasket assembly 612 comprises a gasket 610, which isan elastomeric band extending around the perimeter of the gasket/filter622. When the elastomeric gasket 610 is tightened or stretched, thegasket 610 compresses the filter 620 against the container body 602,thereby creating a seal between the body 602 and gasket/filter 622. Theelastomeric gasket 610 is surrounded by a non-elastic sheath 630 thatdoes not tighten or stretch when the gasket 610 is tightened orstretched to compress against the body 602. The sheath 630 definesopenings or slits 632 therein; the sheath 630 may define such openings632 about the perimeter of the gasket/filter 622. When the gasket 610 isnot compressed, the gasket 610 is not visible through the sheathopenings 632. However, when the gasket 610 is compressed, the gasket 610shifts with respect to the sheath 630 such that the gasket 610 isvisible through the openings 632 in the sheath 630. Additionally oralternatively, the openings 632 may be substantially closed when thegasket 610 is not compressed but are opened as the gasket 610 istightened or stretched about the body 602 such that the gasket 610becomes visible as it is tightened or stretched. The transition from afirst visual state, where the gasket 610 is not visible, to a secondvisual state, where the gasket 610 is visible, thus provides anindication of the seal state of the sterilization container 600.Accordingly, the gasket 610 and sheath 630 together form the sealindicator 616, and the first visual state may be referred to as thefirst indicator state and the second visual state may be referred to asthe second indicator state. Further, in embodiments in which the sheathopenings 632 are defined about the perimeter of the gasket/filter 622,the seal indicator 616 may be visible from all sides of the container600, i.e., from both ends 602 a, 602 b and sides 602 c, 602 d of thebody 602.

Similar to the other seal indicator embodiments described herein, itwill be appreciated that the sheath 630 comprises a first indicium 616 aand the gasket 610 comprises a second indicium 616 b. The first indicium616 a may be a first color or hue and the second indicium 616 b may be asecond color or hue. The first and second colors/hues may be selectedsuch that there is a high contrast between the colors/hues and/orbetween the colors/hues and the sterilization container 600, and/or thecolors/hues may be selected to reinforce the signal communicated by thecolor or hue. For example, in an exemplary embodiment, the first coloris red to indicate the container 300 is unsealed (i.e., contaminantscould enter the container 600 and reach any articles in the interior606), and the second color is green to indicate the container 600 issealed (i.e., contaminants cannot enter the container 600 and anyarticles in the container 600 would remain sterile after sterilization).In another exemplary embodiment, the sheath 630 is the same color as thefilter 620 of the combination gasket/filter 622 and, thus, the firstcolor (i.e., the color of the sheath 630 and filter 620 and, therefore,the vast majority of the gasket/filter 622) may be a more subdued oraesthetically pleasing or calming color than red, such as blue. In suchembodiments, the second color, i.e., the color of the gasket 610, may bea high contrast color with respect to blue, such as red. In any event,the seal indicator 616 is configured to display only the first colorwhen the container 600 is unsealed and to display the second color whenthe container 600 is sealed, such that the seal indicator 616 indicatesa change in the seal state of the container 600 through a change incolor.

As further described herein, a change in state, i.e., from the firstindicator state to the second indicator state or from the secondindicator state to the first indicator state, may be achieved by achange in color, shape, size, position, etc. of the seal indicator 616to signal the container 600 has transitioned from its unsealed state toits sealed state or from its sealed state to its unsealed state. Thus,when the gasket 610 is not compressed, or not fully compressed, suchthat the interior 606 is not sealed against the ingress of contaminants,the container 600 is in its first, unsealed state and the seal indicator616 is in its first indicator state. Similarly, when the gasket 610 isfully compressed, such that the interior 606 is sealed against theingress of contaminants, the container 600 is in its second, sealedstate and the seal indicator 616 transitions from its first indicatorstate to its second indicator state. Other means for indicating the sealstate of the container 600 or the integrity of the gasket 610, e.g.,auditory or other non-visual indicators, may be used as well.

Additionally, each gasket assembly 612 includes means for tightening orstretching the gasket 610 to compress the gasket 610 against the body602, thereby securing the gasket/filter 622 with respect to the body 602such that the container interior 606 is sealed against the ingress ofcontaminants. The tightening or stretching means 634 can include anysuitable mechanism for tightening the gasket 610 about the body 602. Forinstance, as illustrated most clearly in FIG. 15, the tightening orstretching means of the gasket assembly 612 may include a first endmember 636 on a first end of a gasket 610 and a second end member 638 ona second end of the gasket 610. The first end member 636 defines aprojection 640, and the second end member 638 defines a notch or opening642 that is configured to receive the projection 640. As shown in FIG.15, when the projection 640 is not received in the notch 642, the gasket610 is loose, i.e., the gasket 610 is not compressed against thecontainer body 602 and the container 600 is in its unsealed state. Whenthe gasket/filter 622 is positioned on the body 602 and the projection640 of the gasket assembly 612 is received in the notch 642, the secondend of the gasket 610 is pulled to the first end of the gasket 610, andthe gasket 610 is thereby tightened or stretched, i.e., the gasket 610is compressed against the body 602 and the container 600 is in itssealed state. Further, as illustrated in FIG. 14, the body 602 maydefine grooves 601, and the gasket portion 610 of the combinationgasket/filter 622 is received in a groove 601 as the gasket 610 iscompressed against the body 602. The grooves 601 may help keep thegaskets 610 in position with respect to the body 602, e.g., by fittingwithin a groove 601, a gasket 610 is less likely to slip along thevertical direction V, which can help the gasket 610 initially becompressed as well as remain compressed against the body 602. Thegrooves 601 may provide other benefits as well, e.g., fitting into thegrooves 601 as they are tightened or stretched may help the gaskets 610transition from a position in which they are not seen through theopenings 632 in the sheath 630 to a position in which the gaskets 610are seen through the sheath openings 632.

It will be appreciated that the projection 640 and/or the notch 642includes features for preventing the projection 640 from pulling out ofthe notch 642 once the projection 640 is inserted into the notch 642 tocompress the gasket 610 against the body 602. For example, theprojection 640 may have a triangular or wedge shape, where the thin orpointed end of the triangle or wedge is inserted into the notch 642first, and the wider base of the triangle or wedge catches on the secondend member 638 when the projection 640 is pushed or pulled on. Thus, theprojection 640 cannot easily be removed from the notch 642.Additionally, in some embodiments, the projection 640 and notch 642 maybe reversed, e.g., the first end member 636 may define the notch 642 andthe second end member 638 may define the projection 640. Other suitableconfigurations of the tightening/stretching means 634 may be utilized aswell.

As previously described, the exemplary sterilization container 600comprises multiple gasket assemblies 612. Referring to FIG. 13, thetightening/stretching means 634 of each gasket assembly 612 are offsetaround the perimeter of the container 600. That is, thetightening/stretching means 634 of one gasket assembly 612 is positionedat a first location on the perimeter of the container 600, and thetightening/stretching means 634 of another gasket assembly 612 ispositioned at a second location of the perimeter of the container 600,where the second location is different from the first location. In thedepicted embodiment, the second location is laterally spaced apart fromthe first location along the first side 602 c of the body 602. Further,because each gasket 610 extends about the perimeter of the container600, the gaskets 610 are vertically spaced apart from one another.Moreover, each tightening/stretching means 634, including the first andsecond end members 636, 638, protrudes through a vent opening 618 in thelid 604, which, in part, allows features such as tamper evidence to beincorporated into the sterilization container 600 and/or allows theprojection 640 to be secured against retreat from the notch 642. Asillustrated in FIG. 16, at least one projection 640 may define anaperture 644 therein, and a tag 646 may be positioned within theaperture 644. It will be appreciated that the tag 646 may be a tamperevidence tag configured to help a user to ascertain whether an attempthas been made to open the container 600 or whether the container 600 hasbeen opened and resealed, either of which could possibly compromise thesterility of the contents of the container 600. Additionally oralternatively, the tag 646 may serve other purposes. For instance, thetag 646 may include a label that, e.g., specifies the contents of thecontainer 600, the date and time of sterilization, and/or otherpertinent information, or a way to access such information, such as aradio-frequency identification (RFID) tag, a barcode, a matrix ortwo-dimensional barcode (or Quick Response (QR) code), or otherappropriate means for accessing such information.

Accordingly, the sterilization container 600 described with respect toFIGS. 13-16 provides improved sealing of the container interior 606, aswell as an indicator for indicating the state of the seal, i.e., of theintegrity of the seal, between the interfacing components. For instance,the container 600 utilizes a combination gasket/filter 622, i.e., agasket and filter that are integrally formed as a single piece, whichextends across the entire open top portion 608 of the body 602 to form abarrier against contamination of the container contents. The singlepiece gasket/filter completely covering the body 602 minimizesinterfaces, thereby reducing opportunities for contaminants to breachthe container interior 606. Moreover, the combination gasket/filterincorporates a seal indicator 616 to indicate to a user of the container600 whether the interior 606 of the container 600 is sealed against theingress of contaminants, which may indicate to the user that thesterility of the container 600 has been maintained post-sterilization.Of course, other benefits and advantages also may be realized from thesubject matter discussed with respect to FIGS. 13-16.

The present subject matter also provides methods for indicating theintegrity of a gasket of a sterilization container. For example, anexemplary method comprises providing a container body and a containerlid that together define an interior for receipt of articles forsterilization. The container body has an open top portion, and thecontainer lid covers the open top portion to close the sterilizationcontainer. The method also comprises providing a gasket that extendsbetween the container body and the container lid when the container lidis positioned on the container body to seal the interior against aningress of contaminants. Exemplary container bodies, lids, and gasketsare described with respect to the various sterilization containerembodiments 300, 400, 500, 600 discussed herein. Moreover, as describedwith respect to the sterilization container 600, in some embodiments acombination gasket/filter and lid may be used to cover the open topportion of the body and thereby close the sterilization container. Insuch embodiments, the container interior may be defined by the containerbody and combination gasket/filter.

Further, the method comprises providing a seal indicator for indicatinga seal state of the sterilization container. The seal indicator has afirst indicium and a second indicium. The method also comprisesdisplaying the first indicium when the sterilization container is in anunsealed state and displaying the second indicium when the sterilizationcontainer is in a sealed state. The seal indicator is visible to a userof the sterilization container such that the second indicium is notvisible to the user in the unsealed state and the first indicium is notvisible to the user in the sealed state. Moreover, in some embodiments,displaying the second indicium comprises displacing the seal indicatorfrom a first position to a second position. Exemplary seal indicatorsare described with respect to the various sterilization containerembodiments 300, 400, 500, 600 discussed herein. In addition,modifications or extensions of the exemplary method also may be realizedfrom the sterilization container embodiments and other subject matterdiscussed herein.

Additionally, although not described above with respect to everysterilization container embodiment 300, 400, 500, 600, it will beappreciated that each sterilization container includes means for asterilant to enter the container interior to sterilize any articleswithin the container. For example, vents or openings, as shown in thelids of the container embodiments 300, 400, 500, 600 (e.g., in FIGS. 1,6, 7, and 9-16), allow fluids, including a sterilant such as steam or achemical agent, to pass into the sterilization container to sterilizeany articles within the container interior. Further, as describedherein, the vents or openings allow fluids to pass from the containerinterior to the exterior, e.g., to help dry or aerate the articles asthe sterilant evaporates or degases. As further described herein, theseal indicators may be configured such that the sterilization modality,including the sterilant used in the sterilization process, does notaffect the seal indicator. For example, the sterilization modality doesnot cause the seal indicator to transition from displaying a firstindicium to displaying a second indicium; as a particular example, thesterilization modality does not cause the seal indicator to changecolor. However, in some embodiments, the sterilization modality may helpestablish the seal between the container lid and container body and aportion of the sterilization process (such as elevated temperature orpressure) may cause the seal indicator to transition from one indicatorstate to another based on the establishment of the container seal. Insuch embodiments, the seal indicator may be indirectly affected by thesterilization modality, although the seal indicator does not transitionbetween indicator states based solely on the sterilization modality but,rather, in response to the effect of the sterilization modality on thecontainer seal.

Moreover, it will be appreciated that, although not described above withrespect to every sterilization container embodiment 300, 400, 500, 600,the materials of each component of the container are selected to becompatible with the sterilization modality to which the container issubjected. For instance, the container body, container lid, andcontainer gasket are each formed from a material that is compatible withthe sterilization conditions to which the container will be submitted orvice versa, the sterilization conditions for a given container areselected to be within a range compatible with the material capabilitiesof the container materials. For example, the body and lid of eachcontainer 300, 400, 500, 600 can be reusable and can be formed from arigid material such stainless steel, anodized aluminum,polyetheretherketone (PEEK), polyaryletherketone, polyphenylsulphone(PPSU), polysulphone (PSU), filled PPSU, and filled PSU. Once sealed, asdescribed in greater detail herein, the container can then betransferred to sterilizing equipment and exposed to sterilizationconditions as generally known in the art. Such sterilization conditionscan include, for example, steam, ethylene oxide, or hydrogen peroxideplasma sterilization conditions. Sterilization conditions are theconditions present during a particular sterilization methodologyutilized that substantially kills or completely destroys bacteria andother infectious organisms in an industrial or medical product to thedesirable sterility assurance level (e.g., ≥10⁻⁶ log reduction forterminal sterilization). The compatibility of the container materialswith the sterilization modality may be one way in which the sealindicator of the container is unaffected by the sterilization modality.That is, the seal indicator materials may be selected such that theindicator is not induced to transition between indicia based on thesterilization conditions but based on whether the seal between the lidand body is established or broken.

Also, although not described above with respect to every sterilizationcontainer embodiment 300, 400, 500, 600, it will be understood that oneor more tags, such as tamper evidence tags and/or contents labels, maybe included with each sterilization container. For example, a single usetamper evident tag, which breaks upon opening, may be attached to eachsterilization container when the container is sealed. In one embodiment,a tamper evident tag includes a plastic flap across the interfacebetween the container body and lid that tears upon opening. Additionallyor alternatively, other tags or labels may be included with eachsterilization container described herein. For instance, each containermay include a label that, e.g., specifies the contents of the container,the date and time of sterilization, and/or other pertinent information,or a way to access such information, such as a radio-frequencyidentification (RFID) tag, a barcode, a matrix or two-dimensionalbarcode (or Quick Response (QR) code), or other appropriate means foraccessing such information.

Further, it will be appreciated that the sterilization containersdescribed herein may be configured to stack on top of one another orother containers. For example, the lids of the sterilization containersmay provide rigidity, stability, and/or protection for the filter mediasuch that the containers may be stacked. In addition, in embodimentssimilar to the sterilization containers 500 and 600, where the filtermedia is disposed between the lid and body and supports the lid at leastin part, the edges of the filter media may be reinforced to providerigidity for stacking. Moreover, the containers may include features forkeeping space between the containers when stacked such that sterilantand/or evaporating fluids can enter and/or exit the containers throughthe vents. That is, the containers may be configured such that the ventsare not blocked when one container is stacked on top of another.

Additionally, the sterilization containers described herein may includea second lid or cover that fits over the lids described herein, e.g., toprevent intrusions through the vent openings defined in the top of thelid. For example, it will be appreciated that contaminants or otherdebris matter could fall through the vent openings illustrated in theexemplary embodiments of the present subject matter, and suchcontaminants could fall into the container via a compromised filter orwhen the container is opened, thus compromising the sterility of thearticles within the container. A particular example, an instrument endor the like could enter the vent openings, e.g., if the instrument isdropped on the lid, and thereby pierce, puncture, cut, tear, etc. thefilter media that is positioned between the vent openings and thecontainer interior, which could compromise the integrity of the filterand thereby could compromise the sterility of the articles within thecontainer. Therefore, a second lid or cover may be provided to shieldthe vent openings defined in the exemplary lids described herein. Thesecond lid or cover may be releasably attached to the lid or may bedurably attached to the lid. Further, the second lid or cover may itselfhave define openings therein for fluids, such as the sterilant of theselected sterilization modality, to enter and exit the container. Thedefined openings of the second lid or cover are judiciously shaped andsized to ensure the desired Volume to Vent (V-to-V) ratio is maintained.It will be appreciated that such openings may be defined in the secondlid or cover such that such openings do not face the same breachpotential as the vent openings in the underlying lid. Alternatively oradditionally, a gap may be defined between the second lid or cover andthe underlying lid, e.g., around the outer perimeter of the lid, suchthat fluids may enter and exit the container via the gap between the lidand the second lid or cover. The second lid or cover may have otherconfigurations as well, and in some embodiments, such a protective lidor cover may be unnecessary or undesirable and, thus, may be omitted.

This written description uses examples to disclose the invention,including the best mode, and also to enable any person skilled in theart to practice the invention, including making and using any devices orsystems and performing any incorporated methods. The patentable scope ofthe invention is defined by the claims and may include other examplesthat occur to those skilled in the art. Such other examples are intendedto be within the scope of the claims if they include structural elementsthat do not differ from the literal language of the claims or if theyinclude equivalent structural elements with insubstantial differencesfrom the literal language of the claims.

1.-15. (canceled)
 16. A sterilization container, comprising: a body; a lid, the body and lid together defining an interior; a gasket for sealing the interior against an ingress of contaminants; and a seal indicator for indicating a seal state of the sterilization container, the seal indicator having a first indicator state that indicates an unsealed container state and a second indicator state that indicates a sealed container state, wherein the seal indicator is in the first indicator state when the gasket is not compressed to seal the sterilization container against the ingress of contaminants, and wherein the seal indicator is in the second indicator state when the gasket is compressed to seal the sterilization container against the ingress of contaminants.
 17. The sterilization container of claim 16, wherein the gasket is the seal indicator, and wherein the gasket comprises a first indicium to indicate the first indicator state and a second indicium to indicate the second indicator state.
 18. The sterilization container of claim 17, wherein the gasket comprises a top portion, a middle portion, and a bottom portion, wherein at least one of the top portion and the bottom portion include the second indicium, wherein the middle portion includes the first indicium, wherein the middle portion is visible to a user in the unsealed state such that the first indicium is visible to the user, and wherein the middle portion is compressible such that the top portion meets the bottom portion when the gasket is compressed in the sealed state and only the second indicium is visible to the user.
 19. The sterilization container of claim 16, wherein the seal indicator comprises a sheath, the sheath defining openings therein, wherein the gasket is visible through the openings in the sheath when the gasket is compressed to seal the sterilization container.
 20. A sterilization container, comprising: a body; a lid, the body and lid together defining an interior; a closure mechanism for securing the lid to the body; a combination gasket/filter having a gasket for sealing the interior against an ingress of contaminants integrally formed with filter media for forming a barrier between an external environment and the interior; and a seal indicator for indicating a seal state of the sterilization container, the seal indicator having a first indicator state that indicates an unsealed container state and a second indicator state that indicates a sealed container state, wherein the closure mechanism compresses the combination gasket/filter between the lid and the body to seal the interior against the ingress of contaminants, wherein the seal indicator is configured to display a first indicium in the first indicator state, and wherein the seal indicator is configured to display a second indicium in the second indicator state.
 21. (canceled)
 22. The sterilization container of claim 20, wherein the seal indicator is incorporated into the combination gasket/filter.
 23. The sterilization container of claim 22, wherein the lid is formed from a transparent material, wherein the combination gasket/filter, including the seal indicator, is visible from an exterior of the sterilization container.
 24. The sterilization container of claim 20, wherein the combination gasket/filter includes a single use gasket.
 25. The sterilization container of claim 20, wherein the sterilization container further includes a transparent film to form a window into the interior.
 26. The sterilization container of claim 20, wherein the sterilization container further includes a latch assembly including a first end latch, a second end latch, a first side latch, and a second side latch.
 27. The sterilization container of claim 20, wherein the lid defines one or more vents through which the combination gasket/filter is exposed.
 28. The sterilization container of claim 20, wherein the combination gasket/filter is a part of a gasket assembly, wherein the gasket assembly further includes an additional gasket.
 29. The sterilization container of claim 28, wherein the additional gasket comprises an elastomeric band extending around a perimeter of the combination gasket/filter.
 30. A sterilization container, comprising: a body; a lid, the body and lid together defining an interior; a closure mechanism for securing the lid to the body; a combination gasket/filter having a gasket for sealing the interior against an ingress of contaminants integrally formed with filter media for forming a barrier between an external environment and the interior; and wherein the closure mechanism compresses the combination gasket/filter between the lid and the body to seal the interior against the ingress of contaminants.
 31. The sterilization container of claim 30, wherein the combination gasket/filter includes a single use gasket.
 32. The sterilization container of claim 30, wherein the lid defines one or more vents through which the combination gasket/filter is exposed.
 33. The sterilization container of claim 30, wherein the combination gasket/filter is a part of a gasket assembly, wherein the gasket assembly further includes an additional gasket.
 34. The sterilization container of claim 33, wherein the additional gasket comprises an elastomeric band extending around a perimeter of the combination gasket/filter.
 35. The sterilization container of claim 30, wherein the closure mechanism comprises a latch assembly that includes a first arm attached to the lid and pivotable with respect to the lid, a second arm attached to the lid and pivotable with respect to the lid, a pair of first hooks extending from the first arm to the body, and a pair of second hooks extending from the second arm to the body.
 36. The sterilization container of claim 35, wherein the latch assembly further includes a pair of end latches, a first end latch of the pair of end latches attached to the first arm and a second end latch of the pair of end latches attached to the second arm, wherein the first end latch engages a first end catch on the first end of the body, and wherein the second end latch engages a second end catch on the second end of the body. 